Studies

Short Name Acronym Origin Title Study Description Start Date Status
ACUMIN

NCT03369951

Acute Care Unit Tetracycline antibiotic A Phase IV, Open-Label Pharmacokinetic Study of Tetracycline Antibiotic for Injection Following a Single Infusion in Critically-Ill Adults PK/PD of a single infusion of an intravenous tetracycline antibiotic among critically ill adults 2/4/2016 Published
https://pubmed.ncbi.nlm.nih.gov/33168615/
Lay Summary of Results
ADAPT ADAPTive Design Platform Trial for the Evaluation of Antimicrobials for the Treatment of Multiple Resistant Bacterial Pathogens in Bacteremia An innovative initiative to design and simulate a clinical platform trial that is customized to efficiently evaluate multiple experimental antimicrobial therapies for the treatment of multiple categories of infections (HAP/VAP, UTI and IA) due to MDR bacterial pathogens.

http://www.berryconsultants.com/antibiotic-platform-design/

9/10/2015 Completed
AMPI-Crit Assessment of the Microbiome to Predict Infection in Critical Illness

 

Does rapid assessment of the nasopharyngeal microbiome and resistome predict lower respiratory tract infection and improve clinical outcomes in patients with critical illness? Using a cohort currently enrolling at UCSF, this study aims to analyze the lower respiratory tract microbiome and resistome in order to predict lower respiratory tract infection, identify microbial targets, and detect antimicrobial resistance genes to guide empiric therapeutics. 11/14/2019 Canceled
ArROw Antibiotic Resistance in Organ Transplant Multidrug-resistant bacterial infections in solid organ transplant recipients Comprehensive, multicenter study characterizing the clinical and molecular epidemiology of ESBL-producing Enterobacteriaceae bloodstream infections in solid organ transplant recipients. 12/1/2016 Published

https://pubmed.ncbi.nlm.nih.gov/31162785/

https://pubmed.ncbi.nlm.nih.gov/32149327/

https://pubmed.ncbi.nlm.nih.gov/30375298/

https://pubmed.ncbi.nlm.nih.gov/30764770/

 

BCID Film Array Blood Culture ID Panel Clinical and Economic Impact of Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles A prospective, randomized controlled trial with the primary objective being to determine if the BCID test either alone, or in combination with antimicrobial stewardship, will impact the antimicrobial utilization, clinical outcomes, and healthcare costs of patients with bloodstream infections. 12/17/2013 Published
CEF_BP Ceftriaxone Breakpoint Development of a Multicenter Gram-negative Database to Establish Clinically Relevant Antibiotic Breakpoint Interpretative Criteria for Ceftriaxone A retrospective, observational propensity score-matched study of patients 18 years or older with monomicrobial Gram-negative bacteremia with the primary objective being:

to compare clinical outcomes of adult patients with Gram-negative bacteremia with organisms with minimum inhibitory concentrations between 4-8 µg/ml who received ceftriaxone compared with broader-spectrum antibiotic agents

4/10/2014 Published

www.ncbi.nlm.nih.gov/pubmed/29992175

www.ncbi.nlm.nih.gov/pubmed/29190320

www.ncbi.nlm.nih.gov/pubmed/27358356

www.ncbi.nlm.nih.gov/pubmed/25586681

www.ncbi.nlm.nih.gov/pubmed/30667477

CEPCON Pharma Company Controls Collection of Rectal and Oropharyngeal Swabs from Healthy Volunteers Collection of rectal and oropharyngeal swabs from healthy controls for the development of an assay 6/11/2015 Enrollment Complete

Samples used for Platform Validation

CEP-CRO  

Continuous Enrollment Platform – Carbapenem-Resistant Organisms

Continuous Enrollment Platform – Carbapenem-Resistant Organisms Rapid diagnostic PCR test to detect carbapenem-resistant organisms directly in respiratory and urine samples in less than 1 hour. ARLG samples were utilized for development of the Cepheid Carba-R BEU (BAL, ETA, urine) cartridge assay, utilized in a global clinical trial of a novel Gram-negative agent. 2014  

 

Completed

CEP-VAP Continuous Enrollment Platform – Ventilator Acquired Pneumonia Continuous Enrollment Platform – Ventilator Acquired Pneumonia Rapid diagnostic to detect the major organisms responsible for VABP in patients directly in respiratory samples in 1 hour. ARLG samples were utilized to develop a P. aeruginosa platform used to identify colonized patients in an EU VABP clinical trial. 2014  

Completed

 

COATI Creating an Outpatient-specific Antibiogram to guide Treatment for urinary tract Infections Creating an outpatient-specific antibiogram to guide treatment for urinary tract infections A prospective observational study to develop a primary care-specific antibiogram of uropathogens, and identify factors that independently increase or decrease the risk of resistant organisms in primary care patients with UTI. 07/01/2018  

Published

https://www.sciencedirect.com/science/article/abs/pii/S0020748922001547?via%3Dihub

https://pubmed.ncbi.nlm.nih.gov/38217846/ 

COMBINE

NCT03978091

AVYCAZ® in COMBINation with Aztreonam A Phase I, Open-Label Study in Healthy Adults to Evaluate the Safety and Pharmacokinetics of AVYCAZ® in Combination with Aztreonam A single center study in healthy adult subjects to investigate the safety and pharmacokinetics of ceftazidime-avibactam (AVYCAZ) combined with aztreonam (ATM), AVYCAZ alone, and ATM alone. 12/6/2017 Published

doi: 10.1128/aac.00936-22. Online ahead of print.PMID: 36394326

doi: 10.1128/aac.00935-22. Online ahead of print.PMID: 36394316

Lay Summary of  Results

COMBINE HFIM Combination regimen of Cefazidime-Avibactam with Aztronam
Hollow Fiber Infection Model against NDM-1-producing Enterobacteriaceae
Hollow Fiber Infection Model against NDM-1-producing Enterobacteriaceae Hollow fiber infection model (HFIM) studies were conducted to determine the optimal dosing of CAZ-AVI + ATM for efficacy and subsequently evaluate these regimens in a phase I study to assess their safety. 1/1/2018 Published
https://pubmed.ncbi.nlm.nih.gov/32464664/Lay Summary of Results
CRACKLE Consortium on Resistance against Carbapenems in Klebsiella pneumonia Consortium on Resistance against Carbapenems in Klebsiella Pneumoniae and other Enterobacteriaceae An observational study that utilizes an existing CRKP consortium consisting of 20 hospitals that are part of 9 different health care systems. The primary objectives were:

1) To determine whether CRKP strain type is associated with outcomes in CRKP infections 2) To evaluate the constellation of clinical and microbiologic factors associated colistin and tigecycline non-suspectibility

3) To explore variation in treatment and outcomes of CRKP infections in various anatomical sites.

12/6/2013 Published

pubmed.ncbi.nlm.nih.gov/29181422/

pubmed.ncbi.nlm.nih.gov/26850824/

pubmed.ncbi.nlm.nih.gov/29026866/

pubmed.ncbi.nlm.nih.gov/26185273/

pubmed.ncbi.nlm.nih.gov/28167541/

pubmed.ncbi.nlm.nih.gov/26686227/

pubmed.ncbi.nlm.nih.gov/24948759/

pubmed.ncbi.nlm.nih.gov/29456071/

pubmed.ncbi.nlm.nih.gov/28461314/

pubmed.ncbi.nlm.nih.gov/27940944/

pubmed.ncbi.nlm.nih.gov/25990806/

pubmed.ncbi.nlm.nih.gov/25492391/

pubmed.ncbi.nlm.nih.gov/24931918/ 

pubmed.ncbi.nlm.nih.gov/29020404/

pubmed.ncbi.nlm.nih.gov/24798270/

pubmed.ncbi.nlm.nih.gov/24913165/

pubmed.ncbi.nlm.nih.gov/25385117/

pubmed.ncbi.nlm.nih.gov/30014001/

CRACKLE II Consortium on Resistance against Carbapenems in Klebsiella pneumonia and other Enterobacteriaceae Consortium on Resistance against Carbapenems in Klebsiella pneumoniae and other Enterobacteriaceae: A Prospective, Observational Cohort Study A prospective, multicenter, observational cohort study with the objective of providing observational data that will aid in the design of randomized clinical trials on therapeutics and diagnostics for CRE infections. The objectives are:

1) To identify target population and high volume centers

2) Provide data on impact of potential inclusion/exclusion criteria on enrollment in future trials

3) Provide data on expected outcomes of patients with CRE infections for power and sample size calculations for future trials

12/01/2015 Published

https://pubmed.ncbi.nlm.nih.gov/30423056/

https://pubmed.ncbi.nlm.nih.gov/32151332/

https://pubmed.ncbi.nlm.nih.gov/34767753/

Lay Summary of Results

CREST Using Novel Molecular Beacons to study the impact of Carbapenem Resistant Enterobacteriaceae Carriage on the Outcomes of Solid Organ Transplant Using Novel Molecular Beacons to Study the Impact of Carbapenem Resistant Enterobacteriaceae Carriage on the Outcome of Solid Organ Transplant A prospective, observational study to evaluate the natural history of CRE carriage in intestine, liver, lung, pancreas, kidney, and heart transplant donors and recipients from time of transplant through 3 months post-transplant. The primary objectives are:

1) To determine CRE carriage rates among intestine, liver, lung, lung, pancreas, kidney, and heart transplant donors and recipients at time of transplant, and among recipients post-transplant

2) To follow transplant recipients for 3 months post-transplant for the development of CRE infections of colonization

3) To determine associations between CRE colonization, CRE infections, and outcomes like length of hospital stay, and rates of mortality, rejection, and allograft failure

4) To compare sensitivity and turn-around time of molecular beacon and culture-based CRE screening methods, using per-rectal, duodenal, colon, and lung swabs or bronchoalveolar lavage fluid

10/9/2014 Abstract
CRKP-LTACH The epidemiology of Carbapenem-Resistant Klebsiella pneumoniae in long-term acute care hospitals (LTACH) The Epidemiology of Carbapenem-Resistant Klebsiella pneumoniae in long-term Acute Care Hospitals A clinical epidemiologic and microbiologic building on an existing collaboration that will focus on characterization of CRKP isolates from a network of LTACHs, including linkage to clinical epidemiologic characteristics. The primary objectives are:

1) To evaluate risk factors for relatedness of CRKP isolates from LTACH residents

2) To assess the impact of various resistance mechanisms, virulence factors, and capsular gene types on clinical outcomes in the LTACH setting

8/12/2014 Published
DARMA Disparities in Antibacterial Resistance: A Series of Meta-Analyses Disparities in community-acquired, antibacterial-resistant infections in the United States: a series of systematic reviews and meta-analyses A series of systematic reviews of the literature and meta-analyses aiming to rigorously evaluate evidence for the association between US patients’ risk of community-associated antibacterial-resistant infections and their (a) racial or ethnic background and (b) socioeconomic status (SES). 08/10/2023 Data Analysis
DICON I Refers to the Duke Infection CONtrol Network which provides access to the community hospitals doing research A Multi-Center, Three-Stage Cluster-Randomized Historically Controlled Crossover Trial to Determine the Feasibility and Outcomes from Two Antimicrobial Stewardship Interventions in Community Hospitals A multicenter, three-stage cluster-randomized historically controlled crossover trial with the primary objectives being:

1) To evaluate having the protocol of two stewardship intervention strategies approved by hospital administration and committees

2) To evaluate the training of local PharmDs in administration of the two stewardship strategies

3) To evaluate the initiation and implementation of the two stewardship strategies at four hospitals.

8/1/2013 Published

Lay Summary of Results

DIFFR Clostridioides DIFFicile RNA Improved molecular diagnostic approaches to detect C. difficile Study to optimize a novel molecular diagnostic to detect C. difficile toxin mRNA expression in stool, determine its analytical performance characteristics, and evaluate the clinical sensitivity and specificity relative to gold standard methods. 1/1/2020 Manuscript in Progress
DISK Refers to the disk diffusion test method evaluated in the study Rapid Disk Diffusion Test Direct from Patient Blood Cultures for the Detection of Antimicrobial Susceptibility of Gram Negative Rods A multicenter study to evaluate the performance of disk diffusion performed using positive blood culture broth (BCB) as the inoculum.  Because this test uses general purpose reagents, it can be performed in all laboratories including those without the expertise and resources for expensive and complex molecular testing. 8/10/2015 Analysis in Progress
DOTS Dalbavancin as an Option for Treatment of S. aureus Bacteremia Dalbavancin as an Option for Treatment of S. aureus Bacteremia: A Phase 2b, Multicenter, Randomized, Open-Label, Assessor-Blinded Superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients with Complicated S. aureus Bacteremia Multicenter, randomized, open-label, assessor-blinded, superiority study. Compare dalbavancin to the standard of care treatment for the completion of therapy in participants who have complicated S. aureus bacteremia or right-sided native valve infective endocarditis (IE) and who have cleared their baseline bacteremia. 12/2/2019 Data Analysis
ESCAPED Emerging Staphylococcus aureus and Current Antimicrobial  Patterns in Emergency Departments Emerging S. aureus Antimicrobial Resistance and Current Prescribing Practices for Patients Presenting to US Emergency Departments with a Purulent Skin and Soft Tissue Infection A prospective surveillance study aiming to describe the current bacteriology, antimicrobial resistance patterns, resistance risk factors, culture and empiric antibiotic prescribing practices, and strain epidemiology among emergency department (ED)-presenting patients with purulent skin and soft tissue infections (SSTI). 08/10/2023 Study Design
EVADE

NCT02696902

Effort to Prevent Nosocomial Pneumonia caused by Pseudomonas aeruginosa in Mechanically Ventilated Subjects A Phase 2 Proof-of-concept Study to Evaluate the Efficacy and Safety of MEDI3902 in Mechanically Ventilated Patients for the Prevention of Nosocomial Pneumonia Caused by Pseudomonas aeruginosa Prophylactic use of MEDI3902 in mechanically ventilated subjects in the intensive care unit (ICU) who are colonized with Pseudomonas aeruginosa (P aeruginosa) in the lower respiratory tract will reduce the incidence of nosocomial pneumonia caused by P aeruginosa through 21 days post-dose irrespective of mechanical ventilation status at time of diagnosis. 6/30/2017 Closed
FAST Fast Antibiotic Susceptibility Testing for gram-negative bacteremia Fast Antibiotic Susceptibility Testing for Gram-Negative Bacteremia: Prospective, Randomized Trial A prospective, randomized trial to evaluate clinical outcomes among patients with gram-negative bacteremia who have blood culture evaluation using standard methods versus rapid antibiotic susceptibility testing 12/2/2019 Enrolling
FOCUS  The Fosfomycin Oral for Complicated Urinary Syndromes Study A Phase IV Randomized, Double-blinded Trial to Evaluate the Efficacy of Oral Fosfomycin versus Levofloxacin in Complicated Urinary Tract Infections (cUTI) A multi-center, randomized, double-blind, double-dummy, phase IV clinical trial of fosfomycin oral for complicated urinary syndromes.

Main objective: To compare the safety and efficacy of oral fosfomycin to levofloxacin for the treatment of cUTI including pyelonephritis

4/9/2015 Analysis Complete

Manuscript Submitted

FOCUS-PK PAD FOCUS (Pharmacokinetics And Dynamics for FOCUS) Pharmacokinetic Substudy of the Fosfomycin Oral for Complicated Urinary Syndromes (FOCUS) Trial A substudy of the fosfomycin for complicated urinary syndromes (FOCUS), phase IV, multi-center, randomized, double-blind, double-dummy clinical trial comparing the efficacy of oral fosfomycin versus oral levofloxacin as therapy for complicated urinary tract infections. An intensive pharmacokinetic study performed in 40 randomized patients to develop the pharmacokinetic model, which will be used to identify patient covariates that contribute to altered PK. A randomized, placebo-controlled, active control study of oral fosfomycin as a step-down therapy for cUTI. 2/1/2015 Analysis Complete

Manuscript Submitted

GENO-STELLAR GENOmics, Sequencing-based Typing, EpidemioLogy, Linkage, and Antimicrobial Resistance Tool (GENO-STELLAR) GENOmics, Sequencing-based Typing, EpidemioLogy, Linkage, and Antimicrobial Resistance Tool Web-based genomic-epidemiological tool for antimicrobial resistance prediction 6/1/2020 Platform Launched
INNOVATIONS QoL NA Quality of life (QoL) assessments in studies of patients undergoing treatment for intra-abdominal infections, complicated urinary tract infections, skin and skin structure infections, and hospital-acquired or ventilator-associated bacterial pneumonia The first study aims to adapt previously developed process/survey for measuring QoL for bloodstream infections for deployment in clinical trials of antibacterial drugs for common indications. The project includes a) conducting a systematic review of the literature to identify additional concepts, measurement approaches, and gaps to inform a working concept map and b) conducting a subgroup analysis of existing qualitative work by common indications to include: intra-abdominal infection, complicated urinary tract infection, acute bacterial skin and skin structure infection, and hospital acquired/ventilator-associated bacterial pneumonia. 6/18/2020

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Manuscript in Progress

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

INNOVATIONS QoL NA Quality of life (QoL) assessments in studies of patients undergoing treatment for intra-abdominal infections, complicated urinary tract infections, skin and skin structure infections, and hospital-acquired or ventilator-associated bacterial pneumonia The second study involves conducting semi-structured qualitative, concept elicitation interviews with clinicians of patients with complicated urinary tract infections in order to compare perceptions of patient health-related QoL within and across patient-clinician dyads as well as between groups (i.e., patients and clinicians). 6/10/2021 Data Analysis
MASTER GC

NCT02870101

Master Protocol - Gonorrhoeae and Chlamydia testing of extragenital specimens (pNAAT) Performance of Nucleic Acid Amplification Tests for the Detection of Neisseria Gonorrhoeae and Chlamydia trachomatis in Extragenital Sites A cross-sectional study to evaluate the diagnostic accuracy of multiple commercially available nucleic acid amplification tests (NAATs) for detection of Neisseria gonorrhoeae and Chlamydia trachomatis from oropharyngeal and rectal sites.

The main objective: To estimate the sensitivities, specificities, positive predictive values, and negative predictive values for detecting Neisseria gonorrhoeae and Chlamydia trachomatis in rectal and oropharyngeal swabs for each NAAT.

12/2/2014 Published

Lay Summary of Results

Platforms FDA Approved

MASTER RADICAL Master Protocol-Rapid Diagnostics in Categorizing Acute Lung Infections Master Protocol-Rapid Diagnostics in Categorizing Acute Lung Infections: Equivalence study A study to advance the validation of platforms measuring the RADICAL test including an evaluation of the impact of specimen type and specimen storage conditions. 12/2/2019 Enrollment Complete
Analysis in Progress
MASTERMIND-BSI MASTER protocol for evaluating Multiple INfection Diagnostics for rapid detection of BloodStream Infection MASTER protocol for evaluating Multiple INfection Diagnostics for rapid detection of BloodStream Infection A master protocol study of rapid diagnostics for identification of bacteria directly from blood samples. 12/10/2020 Postponed
MASTERMIND-RING MASTER protocol for evaluating Multiple Infection Diagnostics- ResIstant Neisseria Gonorrhoeae MASTER protocol for evaluating Multiple Infection Diagnostics- Resistant Neisseria Gonorrhoeae (MASTERMIND-RING): Direct-from-Specimen Nucleic Acid Amplification Tests for Detection of Ciprofloxacin Resistance in Neisseria gonorrhoeae A cross-sectional, single-visit study to compare the performance of multiple nucleic acid amplification tests (NAATs) to detect ciprofloxacin-resistant and ciprofloxacin-susceptible NG directly from urogenital specimens. 1/17/2023 Start-up
MeChaTeBla Mechanistic and structural characterization of the interaction of a novel antibiotic with clinically relevant β-lactamases Mechanistic and structural characterization of the interaction of a novel antibiotic with clinically relevant β-lactamases The study aims to biochemically characterize the hydrolysis of a novel antibiotic by clinically relevant carbapenemases, as well as the possible inhibition of a novel antibiotic by other β-lactamases, and assess the microbiological activity of a novel antibiotic in combination with avibactam and L-syn CS319. 1/14/2021 Manuscript in Progress
MERINO-4 NA Early oral step-down antibiotic therapy to a novel oral antibiotic versus continued IV therapy with a carbapenem for bloodstream infection with Enterobacterales resistant to ceftazidime or ceftriaxone, ciprofloxacin or levofloxacin and trimethoprim/sulfamethoxazole Multicenter, randomized, controlled trial to evaluate oral stepdown therapy with a novel oral antibiotic as compared to a full course of IV carbapenem therapy in treating patients with bloodstream infections due to Enterobacterales which are resistant to ceftazidime or ceftriaxone, ciprofloxacin or levofloxacin and trimethoprim/sulfamethoxazole. 10/8/2020 Canceled
MicroFIRE Microbiota Colonization in the Presence of Intestinal Fluoroquinolone Resistant E. coli Microbiota Colonization in the Presence of Intestinal Fluoroquinolone Resistant (FQR) E.  coli Men, presenting for transrectal ultrasound guided prostate biopsy at hospital sites, who are colonized with FQR organisms have abnormal fecal microbiome diversity.  Developing tests to analyze this microbiome can inform necessary precautions prior to future medical procedures. The goal is to analyze bacterial strains and their resistance profiles to allow development of rapid PR tests; investigate a rapid PCR test to detect various clonal groups, identify other clonal groups for testing. 4/14/2016 Published

https://www.sciencedirect.com/science/article/pii/S2287888222000393?via%3Dihub

 

NICU-AR Neonatal Intensive Care Unit Antibiotic Resistance No Title:  Data Mining for specific organisms: E. coli, S. aureus, CoNS:

  • Pediatrix has database from 25% US NICUs
  • Infection data, antibiotic prescription data, outcome data
Data mining to produce three articles. 6/1/2013 Published

https://pubmed.ncbi.nlm.nih.gov/26065862/

https://pubmed.ncbi.nlm.nih.gov/26222060/

https://pubmed.ncbi.nlm.nih.gov/25760564/

https://pubmed.ncbi.nlm.nih.gov/26502073/

OPTIMIZE-GNI OPTIMIZation of Beta-lactam Dosing in Critically-Ill Patients with Suspected or Documented Antimicrobial Resistant Gram-Negative Infections with Cystatin C Optimization of Beta-lactam Dosing in Critically-Ill Patients with Suspected or Documented Antimicrobial Resistant Gram-Negative Infections with Cystatin C Phase IV prospective multi-center interventional PK study aimed at developing individualized meropenem and cefepime dosing algorithms for critically-ill patients with suspected or documented antimicrobial resistant gram-negative infections and varying degrees of renal function based on observed Cystatin C serum concentrations 5/11/2023 Start-up
PDP

NCT06181669

 

Pneumonia Direct Pilot Pneumonia Direct Pilot This is a prospective, observational, diagnostic feasibility study (non-IDE) to determine the accuracy of pathogen and host-directed testing for the diagnosis of Ventilator Associated Pneumonia (VAP). 2/9/2023 Start-up
PHAGE
NCT05453578
Study of the Safety and Microbiological Activity of BacterioPHAGEs in Persons with Cystic Fibrosis Colonized with Pseudomonas aeruginosa A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized with Pseudomonas aeruginosa A Phase 1b/2, proof-of-concept, interventional study enrolling cystic fibrosis participants chronically colonized with P. aeruginosa and randomized to receive a fixed anti-pseudomonal phage cocktail to understand the safety and microbiological changes associated with phage therapy. 12/2/2019 On-hold
PHAT Isolation and characterization of lytic PHAges that Target MDR bacteria Isolation and characterization of lytic phages that target MDR bacteria A study to isolate and characterize bacteriophages screened against multidrug resistant bacteria in order to generate species-specific panels of phages. 12/2/2019 Published
https://www.liebertpub.com/doi/full/10.1089/phage.2021.0011 https://pubmed.ncbi.nlm.nih.gov/35620437/
POP-MDRO Prospective Observational Pseudomonas study - Multi-Drug ResistantOrganism Network Prospective Observational Pseudomonas study as part of the Master protocol for prospective, multi-center, observational cohort studies An international, multi-center study using the master protocol for prospective, multicenter, observational cohort studies to provide detailed clinical and microbiologic data in carbapenem-resistant P. aeruginosa (CRPA) pulmonary and bloodstream infections in hospitalized patients to inform future interventional and diagnostic studies. 8/31/2018 Published
https://doi.org/10.1016/S2666-5247(22)00329-9
PRIMERS I-IV Platforms for Rapid Identification of MDR-GNB, and Evaluation of Resistance Studies I-IV Rapid Gene Detection of MDR GNB to Direct and Improve Patient Outcomes A series of diagnostics studies with the goal of identifying efficient, cost-effective platforms with which to discriminate resistant and susceptible antibiotics by identifying and genotyping the bla genes of multi-drug resistant gram-negative bacterial isolates 6/1/2013 PRIMERS I and II

PRIMERS III

PRIMERS IV

 

PROOF

NCT02570074

Phase I Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability of Three Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adult Participants Phase I Study to Evaluate Pharmacokinetics, Pharmacodynamics and Safety/Tolerability of Three Dosing Regimens of Oral Fosfomycin Tromethamine in Healthy Adult Participants A randomized, three-way crossover trial involving up to 24 randomized participants, stratified by gender using permuted blocks, with an anticipated 25% drop-out rate to give a total of 18 evaluable healthy adult participants. The primary study objectives are:

1) To assess the safety and tolerability of three different oral dosage regimens of fosfomycin tromethamine in healthy adult participants

2) To estimate the fosfomycin pharmacokinetic parameters maximum plasma concentration and area-under-the-plasma concentration time-curve at steady-state in three different oral dosage regimens of fosfomycin tromethamine in healthy adult participants

5/29/2015 Published

Lay Summary of Results

https://pubmed.ncbi.nlm.nih.gov/31767717/

PROVIDE Prospective Observational Study to Validate the Pharmacodynamic InDex for Vancomycin among Patients with MRSA Bloodstream Infections Prospective Observational Evaluation of the Association between the Day 2 Vancomycin Exposure and Failure Rates among Adult Hospitalized Patients with MRSA Bloodstream Infections A prospective, multi-center, observational study with the primary objectives:

1) To estimate the difference in failure rates among adult hospitalized patients with MRSA bloodstream infections, who have vancomycin AUDAY2/MICBMD ratios above 650 relative to those with AUCDAY2/MICBMD ratios less than 650

2) To estimate the difference in failure rates among adult hospitalized patients with MRSA bloodstream infections, who have AUCDAY2/MICETEST ratios less than 320

5/7/2014 Published

Lay Summary of Results

RADICAL Rapid Diagnostics in Categorizing Acute Lung Infections A Host-Based mRNA Classifier for Differentiating Viral and Bacterial Etiologies of Acute Respiratory Tract Infection An umbrella protocol plan to develop and evaluate a host-based assay to distinguish between bacterial, viral and non-infectious diseases, which could help reduce inappropriate antimicrobial use. The aims are:

1) To transfer the bacterial signature to an RT-PCR platform

2) To validate and optimize the ARI classifier using the TLDA technology; define performance characteristics compared to existing diagnostic standards

3) To establish a regulatory pathway for commercialization opportunities

4) Early-phase Economic Modeling

5/7/2014 Published

Lay Summary of Results

https://pubmed.ncbi.nlm.nih.gov/26791949/

https://pubmed.ncbi.nlm.nih.gov/30958855/

https://pubmed.ncbi.nlm.nih.gov/31631046/

RADICAL II

NCT03192072

Rapid Diagnostic in Categorizing Acute Lung Infections Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness A cross sectional, single visit study, in adults and children, to evaluate the diagnostic accuracy of a host response test to categorize the etiology of illness in patients presenting with acute respiratory symptoms, as compared to a clinical adjudication reference standard.

1) Compare the Host Response-Acute Respiratory Illness (HR-ARI) test to a clinically adjudicated reference standard with respect to bacterial, viral, or non-bacterial/non-viral (NB/NV) etiologies.

2) Evaluate performance of the HR-ARI test across age groups; (22-64 years; 65 or older), racial and ethnic distributions, and different enrollment sites.

3) Evaluate performance of the HF-ARI test in clinical subgroups such as COPD, immunosuppressed, and those with atypical bacterial pathogens (Legionella pneumophila, Mycoplasma pneumonia, and Chlamydophila pneumonia).

6/06/2016 Published
RADICAL-3 Rapid Diagnostic in Categorizing Acute Lung Infections Rapid Diagnostic in Categorizing Acute Lung Infections Prospective, randomized, interventional, pilot study to estimate the clinical utility of the Host Response-Bacterial/Viral (HR-B/V) test run on a novel platform in Emergency Department patients with acute, febrile respiratory infection. 8/12/2021 Study Design
RADICAL 510k Rapid Diagnostic in Categorizing Acute Lung Infections A Multicenter Clinical Evaluation of a rapid
diagnostic for the differentiation of bacterial
and viral infections
Prospective, multi-site study to assess the performance of host gene expression signature in blood specimens to discriminate between bacterial and viral infections. 8/11/2022 Cancelled
RAPIDS-GN

NCT03218397

Rapid Identification and Susceptibility Testing for Gram-Negative Bacteremia Rapid Identification and Susceptibility Testing for Gram Negative Bacteremia Multi-center, prospective, randomized, controlled trial to evaluate standard culture and antimicrobial susceptibility testing (AST) versus rapid identification and AST for patients with confirmed Gram-negative bacteremia.

The main study objectives are to evaluate the impact of rapid identification and AST on 1) the time to first antibiotic modification in the first 72 hours after randomization, 2) antimicrobial utilization, and 3) clinical outcomes.

7/9/2015 Published

ePublication

Lay Summary of Results

REPORT-ABC Rapid REPORTing of Antimicrobial resistance from Blood Cultures Rapid Reporting of Antimicrobial resistance from Blood Cultures The study is evaluating laboratory reporting practices of rapid testing performed on positive blood cultures. The goal is to idealize the ways in which advanced generation diagnostics are reported to maximize clinical outcomes and minimize clinician confusion, and to describe the current situation in this regard. 10/8/2020 Published
REPROCESS Racial DisparitiEs in CarbaPenem-Resistant Bacteria: EpidemiOlogy and OutComEs of US PatientS Racial Disparities in Patients Infected with Carbapenem-resistant Bacteria: Epidemiology and Outcome of US Patients in the SNAP, CRACKLE, and POP Datasets of the Antibacterial Resistance Leadership Group This study will utilize and analyze data from three ARLG-funded observational studies: SNAP, CRACKLE-2, and POP, to identify factors associated with differences in outcomes among Black and White patients with multi-drug resistant gram-negative infections. 08/10/2023 Data Analysis
RESISTOME RESistance In Stem cell Transplant microbiOME The acquisition and persistence of antibiotic resistance genes in a high-risk pediatric population A prospective observational study to determine the prevalence, and duration of retention of antibiotic resistance genes in a high-risk patient population. 12/1/2017 Published
SAATELITTE

NCT02296320

Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus aureus Alpha Toxin in Mechanically Ventilated Adult Subjects Evaluating 2 dosage levels (MED14893) in mechanically ventilated subjects in the ICU at high risk for S aureus infections who are currently free of S  aureus-related disease but are colonized with S aureus in the lower respiratory tract. Hypothesis of this Phase 2 study is that prophylactic use of MEDI4893 in mechanically ventilated subjects in the intensive care unit (ICU) who are colonized with S aureus in the lower respiratory tract will reduce the incidence of S aureus pneumonia through 30 days post dose irrespective of mechanical ventilation status at time of diagnosis. 6/30/2017 Closed
SCENE Screening for Colonization with Resistant Enterobacterales in Neutropenic Patients with Hematologic Malignancies Screening for Colonization with Resistant Enterobacterales in Neutropenic Patients with Hematologic Malignancies This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization. 12/1/2019 Closed
SCOUT-CAP

NCT02891915

SCOUT (Previous Study) - Community Acquired Pneumonia A Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial to Evaluate Short Course vs. Standard Course Outpatient Therapy of Community Acquired Pneumonia A multi-center, centrally randomized, double-blind, placebo-controlled superiority clinical trial with the primary aim of comparing the composite overall outcome (Desirability of Outcome Ranking, DOOR) among children from 6 months to 5 years of age with CAP, assigned to a strategy of short course (5 days) vs. standard course (10 days) outpatient beta-lactam therapy. 5/7/2014 Published

Lay Summary of Results

MDRO:SHREC

NCT04574596

Study of Highly Resistant Escherichia coli (SHREC) MDRO: Study of Highly Resistant Escherichia coli (SHREC) A prospective, observational, multicenter, case-control study. 5/21/2020 Published

doi: 10.1093/ofid/ofac572

Lay Summary of Results

SNAP-MDRO Study Network of Acinetobacter baumannii as Carbapenem-Resistant Pathogen-Multi-Drug Resistant Organism Network Study Network of Acinetobacter baumannii as Carbapenem-Resistant Pathogen as part of the Multi-Drug Resistant Organism Network An international, multi-center study using the master protocol for prospective, multicenter, observational cohort studies to provide observational data from hospitalized patients that will aid in the design of randomized clinical trials on therapeutics and diagnostics for Carbapenem-Resistant Acinetobacter baumannii (CRAb) infections, as well as identify centers in geographic regions with the highest incidence of infection for future trial site selection. 8/31/2018 Published

doi: 10.1093/cid/ciad556

Lay Summary of Results

SPICES Study of Persistence of Intestinal Colonization with E. coli ST131 Study of Persistence of Intestinal Colonization with E coli ST131 A single-center, prospective, observational study to assess the duration of colonization with the problemative ST131 E. coli strain and identify risk factors for persistence in colonized patients and their household contracts (including pets). Colonization duration is being compared between FQ-R ST131 E. coli, FQ-S ST131 E. coli, and FQ-R E. coli of other sequence types. The study objectives are:

1) Define the duration of gut colonization with FQ-R ST131 strains in individuals and households

2) To identify host and household level risk factors for persistent colonization with FQ-R ST131

8/1/2013 Published

https://academic.oup.com/jid/article/225/12/2197/6494524?login=true#361402160

STAR Short-course Therapy and the Antibiotic Resistome A Sub-Study to Evaluate Alterations in the Antibiotic Resistome and Microbiome in Subjects Who Received Short Course vs. Standard Course Therapy for Community-Acquired Pneumonia as part of DMID protocol #14-0079 SCOUT-CAP sub-study to look at the microbiome of stool and throat swabs in children with different duration of antibiotic therapy for treatment of CAP. 1/7/2015 Published

https://pubmed.ncbi.nlm.nih.gov/35323040/

Lay Summary of Results

STEP FMT Strain Temporal Engraftment and Persistence after Fecal Microbiota Transplantation Strain Temporal Engraftment and Persistence after Fecal Microbiota Transplantation The study aims to determine engraftment dynamics of taxa associated with durable efficacy of fecal microbiota transplantation to further propel development of the next generation of microbiome therapeutics. 3/10/2022 Data Analysis
TRAP-LRTI

NCT03341273

Targeted Reduction of Antibiotics using Procalcitonin in a multi-center, randomized, blinded, placebo-controlled, non-inferiority study of azithromycin treatment in outpatient adults with suspect Lower Respiratory Tract Infections (LRTI) and a procalcitonin level of < 0.1 ng/mL Targeted Reduction of Antibiotics using Procalcitonin in a multi-center, randomized, blinded, placebo-controlled non-inferiority study of azithromycin treatment in outpatient adults with suspect lower respiratory tract infection (LRTI) and a procalcitonin level of < 0.1 ng/mL The goal of this study is to demonstrate the ability of a biomarker test to identify a patient population in which antibacterial treatment provides no clear benefit. This is a multi-center, randomized, placebo-controlled, non-inferiority study of azithromycin treatment in adults vs. placebo with suspect lower respiratory tract infection and a procalcitonin level of <0.1 ng/mL. The overall goal is:

To determine whether a PCT level < 0.1 ng/mL identifies a subgroup of patients with lower respiratory tract infection (LRTI) who do not require antibiotic therapy versus placebo in patients with suspect LRTI and PCT levels of <0.1

1/7/2015 Published

Lay Summary of Results Available

VENOUS Prospective Evaluation of Clinical Outcomes of Cancer Patients with Vancomycin-Resistant ENterococcUS faecium (VRE) Bacteremia Prospective Evaluation of Clinical Outcomes of Cancer Patients with Vancomycin-Resistant Enterococcus faecium (VRE) Bacteremia This study is a multi-site observational study to prospectively evaluate the outcomes of patients with VRE BSIs treated with DAP and compare the outcomes stratifying by MIC. The study will obtain clinical information of cancer patients with VRE BSIs in an attempt to support the data-driven hypothesis that patients infected with DAP-S VRE isolates with a DAP MIC close to the breakpoint (3-4  μg/mL) are more likely to fail DAP therapy. Isolates will be collected to confirm their species and repeat the DAP MIC using Etest in a standardized and centralized manner. Isolates will remain available to perform further molecular testing in subsequent studies attempting to identify genetic signatures that may predict DAP failure. 4/14/2016 Published

https://pubmed.ncbi.nlm.nih.gov/29760141/
https://pubmed.ncbi.nlm.nih.gov/35155713/