Table 1.
List of Antibacterial Resistance Leadership Group Diagnostic Studies
| Study Name | Description | Status |
|---|---|---|
| BCID: Randomized Trial of Blood Culture Pathogen Identification using the FilmArray Blood Culture Identification Panel | Randomized controlled trial to evaluate an effect of rapid blood culture diagnostic on outcomes | Complete [1] |
| CEP-CON: Cepheid Control | Collection of oral and rectal swabs for development of an assay for Neisseria gonorrhoeae and Chlamydia trachomatis | Ongoing |
| CEP-CRO: Cepheid-Diagnostic for Carbapenem Resistant Organisms | Collection of endotracheal aspirate and bronchoalveolar lavage fluid matrix for development of an assay detecting carbapenem-resistant organisms | Complete |
| CEP-VAP: Cepheid-Diagnostic for Ventilator Associated Pneumonia | Collection of bronchoalveolar lavage fluid matrix for development of pathogen-detection assays | Complete |
| Diagnostics Working Group | Collaboration of industry partners, Antibacterial Resistance Leadership Group, and regulators to discuss diagnostic challenges and solutions | Ongoing |
| MASTERMIND-CT/NG: Master Protocol for Evaluating Multiple Infection Diagnostics–Chlamydia trachomatis/Neisseria gonorrhoeae | MASTERMIND study evaluating multiple companies’ diagnostics for extragenital C. trachomatis and gonorrhea infections | Protocol development; enrollment preparation [6] |
| PRIMERS I–IV: Platforms for Rapid Identification of MDR-Gram negative Bacteria and Evaluation of Resistance Studies I–IV | Development of platforms to rapidly identify antibiotic-resistant gram-negative bacteria: • PRIMERS I: Evaluation of 72 Enterobacteriaceae isolates on 4 RMD platforms • PRIMERS II: Evaluation of 196 Enterobacteriaceae isolates on 2 RMD platforms • PRIMERS III: Evaluation of 200 Acinetobacter isolates on 2 RMD platforms • PRIMERS IV: Evaluation of 197 Pseudomonas aeruginosa isolates on 3 RMD platforms |
Complete [2]Complete [2]Complete [3, 4]Complete [5] |
| RADICAL: Rapid Diagnostics in Categorizing Acute Lung Infections | Development and validation of host gene expression classifiers of bacterial, viral, or noninfectious illness in patients with acute respiratory illness | Enrollment complete; platform development and validation |
| RAPIDS-GN: Rapid Diagnostics for Gram- Negative Bacteria in Blood | Determination of the effect of rapid antimicrobial susceptibility testing on outcomes in patients with gram-negative infections | Protocol development |
| TRAP-LRTI: Use of Procalcitonin Testing to Direct Antibiotic Use in Lower Respiratory Tract Infections | Randomized, placebo-controlled trial of azithromycin vs placebo in patients with lower respiratory tract infection and a low procalcitonin | Protocol development |
Abbreviations: MDR, multidrug resistant; RMD, rapid molecular diagnostic.