Studies In Progress

Short Name Acronym Origin Title Study Description Start Date Status
ACUMIN Acute Care Unit Minocycline A Phase IV, Open-Label Pharmacokinetic Study of Minocycline for Injection Following a Single Infusion in Critically-Ill Adults A Phase IV open-label pharmacokinetic study of a single infusion of IV minocycline in critically-ill ICU adults, with suspected bacterial infection. The primary objectives are: 1) To develop a population PK model for minocycline in critically-ill ICU patients with gram negative infections

2) To assess patient-level and clinical covariates associated with minocycline pharmacokinetic properties in critically-ill patients.

Unknown Protocol Final Development
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. The team consists of statisticians and clinicians from Berry Consultants, ARLG, GSK, Roche, AstraZeneca, The Medicines Company, JHU, BARDA, Sanofi, and the FDA.

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

9/10/2015 Manuscript in progress
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  Manuscript in CID
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 Analysis in progress
CEPCON Cepheid Controls Collection of Rectal and Oropharyngeal Swabs from Healthy Volunteers Collection of rectal and oropharyngeal swabs from healthy controls for background matrix purposes for Cepheid to complete assay validation. 6/11/2015 Protocol Final Development
CRACKLE Consortium on Resistance against Carbapenems in Klebsiella pneumoniae Consortium on Resistance against Carbapenems in Klebsiella Pneumoniae 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 Complete
CRACKLE II Consortium on Resistance against Carbapenems in Klebsiella pneumoniae 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

Unknown Enrolling
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 Manuscript in progress
CRKP-LTACH The epidemiology of Carbapenem-Resistant Klebsiella pneumoniae in long-term acute care hospitals 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 Analysis in progress
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 committees2) To evaluate the training of local PharmDs in administration of the two stewardship strategies3) To evaluate the initiation and implementation of the two stewardship strategies at four hospitals.
8/1/2013 Protocol Development
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 RAPIDS-GN sub-study. This is a multi-center study of the rapid disk diffusion antimicrobial susceptibility test (AST) method using aliquots from positive blood culture bottles that contain Gram negative rods (Enterobacteriaceae, Pseudomonas, and Acinetobacter) identified by reference disc diffusion and microbroth dilution methods. Study design and the number of isolates to be tested are in accordance with Clinical and Laboratory Standards Institute (CLSI) guidance document and the results will be submitted to CLSI for consideration as a new AST standard. This could improve antimicrobial stewardship initiatives Unknown Protocol Development
DOTS Randomized, Open-Label, Superiority Trial of Daptomycin with Oral Tedizolid  Stepdown versus Standard Intravenous Therapy for Staphylococcus aureus Bacteremia Randomized, Open-Label, Superiority Trial of Daptomycin with Oral Tedizolid Stepdown versus Standard Intravenous Therapy for Staphylococcus aureus Bacteremia A multi-center, randomized, open-label study comparing two treatment strategies:

1) Initial daptomycin therapy (8 mg/kg IV q24h) for 14 days (or an anti-staphylococcal beta-lactam for those with MSSA), followed by oral tedizolid (200mg po 24h) for 21 additional days

2) Standard of Care, consisting of daptomycin (8mg/kg) for 14-42 days for subjects with MRSA, or an antistaphylococcal beta-lactam for subjects with MSSA

5/14/2015 Protocol Development
FOCUS  The Fosfomycin Oral for Complicated Urinary Syndromes Study The Fosfomycin Oral for Complicated Urinary Syndromes Study 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 Out for bid
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. Unknown Planning
MASTER GC 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.

1/7/2015 Protocol Development complete
NICE Novel Investigational Clinical Endpoint (NICE) Novel Investigational Clinical Endpoint Substudy of the Fosfomycin Oral for Complicated Urinary Syndromes (FOCUS) Trial A substudy of the fosfomycin for complicated urinary syndromes, 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. This study will use a novel, objective clinical outcome endpoint in the mITT population to assess efficacy, as well as a composite of efficacy and safety, for the treatment of cUTI. The novel endpoint seeks to overcome several limitations of the traditional combination clinical and microbiological response endpoint. 7/9/2015 Planning
PK2 Pharmacokinetics of Plazomicin in Kids Phase I, Open-Label Study to Evaluate the Pharmacokinetics of Plazomicin in Adolescents, Children, and Infants Prospective, multi-center, open-label, multiple-dose Phase I PK study of intravenous plazomicin. A multi-dose design of 1 dose per day for up to 3 days was selected to maximize potential benefit to study participants, as a single dose is unlikely to be therapeutic. The potential benefit of increased MDR gram- negative coverage compared to existing agents using a multiple dose design favorable shifts the risk-benefit profile for this study.

The primary objective is: To determine the PK of IV plazomicin in infants, children, and adolescents

Unknown Protocol Development
PRIMERS Platforms for Rapid Identification of MDR-GNB, an Evaluation of Resistance Study 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-IV complete
PROOF Phase I Study to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety/Tolerability of Three Dosing Regimens oOral 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 Analysis in progress
PROPEL PhaRmacokinetics OPlazomicin in the Epithelial Lining A Phase I, Prospective, Multi-Center, Randomized Study to Evaluate the Epithelial Lining Fluid (ELF) Penetration of Plazomicin in Patients with Nosocomial Pneumonia A Phase I, prospective, multi-center, randomized study to evaluate the epithelial lining fluid (ELF) penetration of plazomicin in patients with nosocomial pneumonia. The primary objective is:

To characterize the intrapulmonary penetration of plazomicin patients with nosocomial pneumonia based on plazomicin concentrations in ELF and plasma following single or multiples doses of plazomicin

Unknown Protocol Development
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 Analysis in progress
RADICAL Rapid Diagnostics iCategorizing 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 work with bioFire Diagnostic Systems to develop a platform to improve turn-around time and feasibility time

4) To establish a regulatory pathway for commercialization opportunities

5) Early-phase Economic Modeling

5/7/2014 Enrollment complete
RAPIDS-GN Rapid Identification and Susceptibility Testing for Gram-Negative Bacteremia Rapid Identification and Susceptibility Testing for Gram Negative Bacteremia A multi-center, prospective, randomized, controlled, factorial design trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with BSIs caused by GNB who receive:

1) Standard culture and antimicrobial susceptibility testing (AST)

2) Standard culture and AST plus bacteremia-focused antimicrobial stewardship program oversight

3) Rapid identification and AST

4) Rapid identification and AST with bacteremia-focused antimicrobial stewardship program oversight

7/9/2015 Protocol Development
SCOUT-CAP 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 Enrolling
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 Planning
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 Pending samples from SCOUT-CAP
TRAP-LRTI 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

Unknown Protocol Development
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. Unknown Initiated
Microfire MICRObiota Colonization in the Presence of Intestinal FluoroquInolone Resistant E. coli Microbiota Colonization in the Presence of Intestinal Fluoroquinolone Resistant E. coli The study is a multi-site observational study to investigate the microbiome differences in men with and without fluoroquinolone resistant organisms found on rectal culture prior to prostate biopsy. The primary objective is: To identify the relative abundance in patients with and without fluoroquinolone resistant E. coli that have colonized the intestine. The secondary aim is: To detect common protective bacteria, such as Bifidobacterium species and Akkermansia muciniphila. Future application of the information gathered may include microbiome manipulation to reduce infection rates, and lead to further research in prostatistis and UTI Unknown Preliminary Data Testing