Table 1.
Recent Investigator-initiated and Industry-sponsored Staphylococcus aureus Bacteremia Clinical Trials
| Study | Intervention | Study Design | Proposed Sample Size | Outcome | Status |
|---|---|---|---|---|---|
| Investigator-initiated trials | |||||
| ARREST (ISRCTN37666216) |
Adjunctive rifampin vs placebo, each in combination with standard of care for SAB | Double-blind RCT | 758 | Microbiologic failure, disease recurrence, or death at 12 weeks | Completed [9] |
| National Institutes of Health algorithm (NCT01191840) |
Algorithm-based therapy for staphylococcal bacteremia | Open-label RCT | 509 | Treatment success, safety, and duration of antibiotic therapy | Completed, results in review [10] |
| CAMERA-1 (ACTRN12610000940077) |
Addition of flucloxacillin to vancomycin for MRSA bacteremia | Open-label pilot RCT | 60 | Duration of bacteremia | Completed [11] |
| CAMERA-2 (NCT02365493) |
Addition of a beta-lactam antibiotic to standard therapy for MRSA bacteremia | Open-label RCT | 440 | Complication-free 90-day survival | Recruiting |
| SABATO (NCT01792804) |
Early intravenous to oral antibiotic switch in uncomplicated SAB | Open-label RCT | 430 | SAB-related complications at 90 days | Recruiting |
| BACSARM (NCT01898338) |
Fosfomycin vs placebo, in combination with daptomycin, for MRSA bacteremia | Open-label RCT | 167 | Clinical response 6 weeks after the end of therapy | Enrollment completed |
| Industry-sponsored trials | |||||
| Primary treatment | |||||
| Daptomycin (NCT00093067) |
Daptomycin vs standard of care for SAB including endocarditis | Open-label RCT | 236 | Treatment success 42 days after the end of therapy | Completed [6] |
| ASSURE (NCT00062647) |
Telavancin vs standard of care for uncomplicated SAB | Double-blind RCT | 58 | Success at 12 weeks | Completed [12] |
| Dalbavancin (NCT03148756) |
Dalbavancin vs standard of care for therapy completion for complicated bacteremia and endocarditis | Open-label RCT | … | Success at 12 weeks | Study terminated by sponsor |
| Telavancin (NCT02208063) |
Telavancin vs standard of care for SAB, including right-sided endocarditis | Open-label RCT | 248 | Success at 8 weeks | Study terminated by sponsor |
| Ceftobiprole (NCT03138733) |
Ceftobiprole vs daptomycin for SAB, including right-sided endocarditis | Double-blind RCT | 390 | Success at 10 weeks | Recruiting |
| Adjunctive immunotherapeutics and other novel approaches | |||||
| CF-301 (NCT03163446) |
CF-301 (a lysin) vs placebo added to standard therapy for SAB | Double-blind RCT | 115 | Adverse events, day 14 clinical outcome | Recruiting |
| SAL200 (NCT03089697) |
SAL200 (a lysin) vs placebo for patients with persistent SAB | Double-blind RCT | 50 | Safety | Recruiting |
| Tefibazumab (Inhibitex, Alpharetta, GA) (NCT00198302) |
Human monoclonal anti-ClfA antibody vs placebo added to standard therapy for SAB | Double-blind RCT | 63 | Safety, new SAB complication, relapse or death at 8 weeks | Completed [13] |
| Altastaph (Nabi Biopharmaceuticals, Rockville, MD) (NCT00063089) |
Pooled human anticapsular polysaccharides 5 and 8 antibody vs placebo added to standard therapy for SAB | Double-blind RCT | 40 | Safety, time to resolution of bacteremia, and defervescence | Completed [14] |
| Aurograb (Novartis, Basel, Switzerland) (NCT00217841) |
Single-chain antibody variable fragment against the ABC transporter component GrfA vs placebo added to vancomycin for severe, deep-seated staphylococcal infections | Double-blind RCT | 180 | Clinical and bacterial response | Completed, results not published |
| 514G3 (NCT02357966) |
Human monoclonal antibody against SpA [15] vs placebo added to standard therapy for SAB | Double-blind RCT | 52 | Safety, time to resolution of bacteremia and defervescence, duration of hospital stay | Enrollment completed |
| DSRA4637S (Genentech, San Francisco, CA (NCT03162250) |
Human monoclonal antibody against S. aureus wall-teichoic acids conjugated to a rifamycin derivative [16] vs placebo added to standard therapy for SAB | Double-blind RCT | 24 | Safety | Recruiting |
Abbreviations: ARREST, Adjunctive Rifampicin to Reduce Early Mortality from S. aureus Bacteraemia; ASSURE, Telavancin for Treatment of Uncomplicated S. aureus Bacteremia; BACSARM, Bacteremia due to Methicillin-Resistant S. aureus; CAMERA, Combination Antibiotic Therapy for Methicillin-Resistant S. aureus Infection; MRSA, methicillin-resistant S. aureus; RCT, randomized controlled trial; S. aureus, Staphylococcus aureus; SAB, S. aureus bacteremia; SABATO, S. aureus Bacteremia Antibiotic Treatment Options.