ADAPT

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/

RESISTOME

Duke RESISTOME (RESistance In Stem cell Transplant microbiome)

TITLE

The acquisition and persistence of antibiotic resistance genes in a high-risk pediatric population

DESCRIPTION
Aim 1: To determine the cumulative prevalence of antibiotic resistance genes in high-risk patients with frequent and prolonged contact with the healthcare system. We will evaluate clinical factors that predict acquisition of resistance genes and identify specific commensal bacteria and microbial community types that reduce the risk of acquisition of antibiotic resistance genes.
Aim 2: To evaluate the duration of retention of bacterial antibiotic resistance genes in a high-risk patient population. We will examine the persistence of antibiotic resistance genes in the gut microbiota of pediatric HSCT recipients after removal of the following selective pressures: 1) antibacterial therapy, 2) lack of enteral feeding, and 3) hospitalization.

VENOUS

Vancomycin-resistant ENterococci OUtcomes Study

TITLE

Prospective Evaluation of Clinical Outcomes of Cancer Patients with Vancomycin-Resistant Enterococcus faecium (VRE) Bacteremia

DESCRIPTION
Prospective study in cancer patients 18 years of age and older to evaluate the outcomes of patients with Vancomycin-Resistant Enterococcus faecium (VRE) bloodstream infections (BSIs) treated with Daptomycin (DAP) to compare clinical outcomes stratifying by minimum inhibitory concentration (MIC).

ACUMIN

TITLE
A Phase IV Open-Label Pharmacokinetic Study of Minocycline for Injection Following a Single Infusion in Critically-Ill Adults

Description
Characterize minocycline PK at the population level in critically-ill adults, with illness known or suspected to be caused by infection with Gram-negative bacteria. To assess patient-level and clinical covariates associated with minocycline pharmacokinetic properties in the same patient population.

CEF_BP

Ceftriaxone Breakpoint

TITLE

Multi-center gram negative database to establish clinically relevant antibiotic breakpoint interpretive criteria for Ceftriaxone

DESCRIPTION
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

BCID

Film Array Blood Culture ID Panel
TITLE

Clinical and economic impact of rapid identification and susceptibility testing of pathogens growing in blood culture bottles. (Note: seed grant is to support economic analysis portion of the study)

DESCRIPTION
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

SCOUT-CAP

SCOUT (Previous Study) – Community Acquired Pneumonia

TITLE

A Phase IV Double-Blind, Placebo-Controlled, Randomized Trial to Evaluate Short Course vs Standard Course Outpatient Therapy of Community Acquired Pneumonia in Children (SCOUT-CAP)

DESCRIPTION
Evaluating short-course vs standard therapy of oral antibiotics on children with Pneumonia