Table 1.
List of Recently Completed and New Antibiotic Leadership Group Diagnostic Studies
| Study | Primary Objective | Design | Status |
|---|---|---|---|
| MASTERMIND-GC | Determine test characteristics of multiple NAATs for the diagnosis of extragenital gonorrhea and chlamydia to enable FDA clearance for a new testing indication (ie, new specimen type) | Observational | Complete |
| MASTERMIND-RING | Determine test characteristics of multiple NAATs for the detection of ciprofloxacin-resistant versus -sensitive gonorrhea directly in clinical specimens to enable FDA clearance of new tests | Observational | Design phase |
| MASTERMIND-BSI | Determine test characteristics of multiple tests for the direct detection of bacterial bloodstream infection to enable FDA clearance of new tests | Observational | Study set-up |
| RAPIDS-GN | Assess the impact of a rapid organism identification, with or without rapid phenotypic AST, from positive BCs on antibiotic prescribing and patient outcomes | Interventional | Complete |
| FAST | Assess clinical outcomes among patients with GN bloodstream infections who have rapid phenotypic AST versus standard culture and AST from BCs in areas with a high prevalence of AR | Interventional | Study set-up |
| TRAP-LRTI | Compare outcomes for patients with signs of non-pneumonia LRTI and a low PCT level who are treated with azithromycin or placebo | Interventional | Complete |
| RADICAL-2 | Determine the test characteristics of a novel host gene expression profile differentiating bacterial from viral ARIs | Observational | Complete |
| RADICAL-3 | Determine the clinical impact of the rapid host-based diagnostic on antibacterial use and clinical outcomes among patients with ARI | Interventional | Design phase |
| RADICAL-510(k) | Determine the test characteristics of the host gene expression profile for differentiating bacterial from viral ARIs in an FDA registrational trial | Observational | Design phase |
| PDP | Assess the accuracy and predictive of pathogen- and host-directed tests for an adjudicated diagnosis of VAP | Observational | Study set-up |
| REPORT-ABC | Evaluate community and academic hospital reporting practices for AR markers included in rapid molecular BC identification panels | Survey | Complete |
Abbreviations: AR, antimicrobial resistance; ARI, acute respiratory illness; AST, antibiotic susceptibility testing; BC, blood culture; FAST, Fast Antibiotic Susceptibility Testing for Gram-negative Bacteremia; FDA, US Food and Drug Administration; GN, gram-negative; LRTI, lower respiratory tract infection; MASTERMIND-BSI, Master Protocol for Evaluating Multiple Infection Diagnostics for Rapid Detection of Bloodstream Infection; MASTERMIND-GC, Master Protocol for Evaluating Multiple Infection Diagnostics–Gonorrhoeae and Chlamydia Testing of Extragenital Specimens; MASTERMIND-RING, Master Protocol for Evaluating Multiple Infection Diagnostics–Resistant Neisseria gonorrhoeae; NAAT, nucleic acid amplification test; PCT, procalcitonin; PDP, Pneumonia Direct Pilot; RADICAL, Rapid Diagnostics in Categorizing Acute Lung Infections; RAPIDS-GN, Rapid Identification and Phenotypic Susceptibility Testing for Gram-negative Bacteremia; REPORT-ABC, Reporting of Antimicrobial Resistance from Blood Cultures; TRAP-LRTI, Targeted Reduction of Antibiotics using Procalcitonin in Lower Respiratory Tract Infection; VAP, ventilator-associated pneumonia.