ARLG 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 | Pharmacokinetics (PKs)/Pharmacodynamics (PDs) of a single infusion of an intravenous tetracycline antibiotic among critically ill adults | 2/4/2016 | Published DOI: 10.1128/AAC.01809-20 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 (hospital-acquired pneumonia [HAP]/ventilator-associated pneumonia [VAP], urinary tract infection [UTI], and invasive aspergillosis [IA]) due to multidrug resistant (MDR) bacterial pathogens. http://www.berryconsultants.com/antibiotic-platform-design/ | 9/10/2015 | Completed |
| CEP-CRO | Continuous Enrollment Platform – Carbapenem-Resistant Organisms | Continuous Enrollment Platform – Carbapenem-Resistant Organisms | Rapid diagnostic polymerase chain reaction (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 a European Union (EU) VABP clinical trial. | 2014 | Completed |
| 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 |
| 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 DOI: 10.1128/aac.00935-22 Lay Summary of Results |
| CRACKLE | Consortium on Resistance against Carbapenems in Klebsiella pneumoniae | Consortium on Resistance against Carbapenems in Klebsiella Pneumoniae and other Enterobacteriaceae | An observational study that utilizes an existing carbapenem-resistant Klebsiella pneumoniae (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-susceptibility 3) To explore variation in treatment and outcomes of CRKP infections in various anatomical sites. | 12/6/2013 | Published DOI: 10.1093/ofid/ofx216 DOI: 10.1016/j.cmi.2016.01.023 DOI: 10.1093/ofid/ofx157 DOI: 10.1128/AAC.00553-15 DOI: 10.1128/AAC.02243-16 DOI: 10.1017/ice.2015.298 DOI: 10.1128/genomeA.00558-14 DOI: 10.1016/j.diagmicrobio.2018.01.005 DOI: 10.1128/AAC.00454-17 DOI: 10.1093/cid/ciw805 DOI: 10.1017/ice.2015.118 DOI: 10.1093/jac/dku495 DOI: 10.1111/1469-0691.12714 DOI: 10.1093/cid/cix783 DOI: 10.1128/AAC.02636-14 DOI: 10.1128/AAC.00125-14 DOI: 10.1128/AAC.04037-14 DOI: 10.1093/ofid/ofy054 |
| CRACKLE II NCT03646227 | Consortium on Resistance against Carbapenems in Klebsiella pneumoniae 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 Carbapenem-resistant Enterobacterales (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 | 12/1/2015 | Published DOI: 10.1093/cid/ciy694 DOI: 10.1016/S1473-3099(19)30755-8 DOI: 10.1016/S1473-3099(21)00399-6 DOI:10.1093/jac/dkae186 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 | Published DOI: 10.1128/aac.02097-16 DOI: 10.1128/aac.02534-16 |
| 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 DOI: 10.1001/jamanetworkopen.2019.9369 Lay Summary of Results |
| 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 | Data Analysis |
| DOTS NCT04775953 | 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 | Published DOI: 10.1001/jama.2025.12543 |
| 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 NCT06174649 | 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 | Manuscript Submitted |
| FOCUS NCT03697993 | 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 | Published DOI: 10.1128/mbio.01677-23 |
| 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 | Published Read the manuscripts |
| 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 | Manuscript Submitted |
| 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 DOI: 10.1093/cid/ciz1105 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 | Published DOI:10.1001/jamanetworkopen.2022.7299 |
| MASTERMIND-RING | MASTER protocol for evaluating Multiple INfection Diagnostics- ResIstant Neisseria Gonorrhoeae | MASTER Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae | A cross-sectional study to evaluate the diagnostic accuracy of investigational reflex tests applied directly to urogenital and pharyngeal specimens to detect the mutant allele of DNA gyrase (gyrA 91F) that predicts ciprofloxacin resistance in Neisseria gonorrhoeae or the wildtype allele (gyrA 91S) that predicts ciprofloxacin susceptibility in N. gonorrhoeae. | 1/17/2023 | Enrolling |
| 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 intravenous (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 |
| NICU-AR | Neonatal Intensive Care Unit Antibiotic Resistance | No Title: Data Mining for specific organisms: E. coli, S. aureus, CoNS:
| Data mining to produce three articles. | 6/1/2013 | Published DOI: 10.1097/INF.0000000000000769 DOI: 10.1097/INF.0000000000000850 DOI: 10.1097/INF.0000000000000573 DOI: 10.1001/jamapediatrics.2015.2380 |
| OPTIMIZE-GNI NCT06709521 | 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, multicenter study comparing the abilities of Cystatin C (CysC) and CysC-based eGFR equations to characterize the pharmacokinetic profiles of meropenem and cefepime relative to serum creatinine (SCR), SCR-based equations, and iohexol in critically ill patients with suspected or documented AMR Gram-negative infections. | 5/11/2023 | Enrolling |
| 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 | Data Analysis |
| 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 | Data Analysis |
| 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 DOI: 10.1016/S2666-5247(22)00329-9 Lay Summary of Results |
| PRIMERS I-IV | Platforms for Rapid Identification of MDR-GNB, and Evaluation of Resistance Studies I-IV | Rapid Gene Detection of MDR Gram-negative Bacteria (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 | Published DOI: 10.1093/cid/civ837 DOI: 10.1128/JCM.01524-16 DOI: 10.1093/cid/ciy80 |
| 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 DOI: 10.1128/AAC.00464-18 DOI: 10.1128/AAC.02102-19 Lay Summary of Results |
| 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, multicenter, observational study with the primary objectives: 1) To estimate the difference in failure rates among adult hospitalized patients with methicillin-resistant Staphylococcus aureus (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 DOI: 10.1093/cid/ciz460 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 a reverse transcription–polymerase chain reaction (RT-PCR) platform 2) To validate and optimize the acute respiratory infection (ARI) classifier using the TaqMan low-density array (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 DOI: 10.1093/cid/ciz437 DOI: 10.1126/scitranslmed.aad6873 DOI: 10.1371/journal.pone.0214871 DOI: 10.1016/j.ebiom.2019.09.040 Lay Summary of Results |
| 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 | Canceled |
| 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 chronic obstructive pulmonary disease (COPD), immunosuppressed, and those with atypical bacterial pathogens (Legionella pneumophila, Mycoplasma pneumonia, and Chlamydophila pneumonia). | 6/6/2016 | Published DOI: 10.1097/CCM.0000000000005085 |
| 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 DOI: 10.1093/cid/ciaa528 DOI: 10.1128/spectrum.01789-24 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 DOI: 10.1093/cid/ciac952 |
| 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 | Terminated prior to US enrollment |
| 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 | Manuscript in Progress |
| 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 community-acquired pneumonia (CAP), assigned to a strategy of short course (5 days) vs. standard course (10 days) outpatient beta-lactam therapy. | 5/7/2014 | Published DOI: 10.1001/jamapediatrics.2021.5547 Lay Summary of Results |
| SHREC (MDRO) 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: 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 DOI: 10.1093/infdis/jiab638 |
| STAR (sub-study of SCOUT-CAP) NCT02891915 | 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 DOI: 10.1093/infdis/jiac082 DOI: 10.1128/mbio.00195-22 Lay Summary of Results |
| 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 DOI: 1016/S1473-3099(22)00735-6 Lay Summary of Results |
ARLG Mentee Projects