drugset / Trial / NCT05394298
Short vs Long of Usual Treatment for Non Complicated Enterococcal Bacteremia
Phase 4
Unknown
284 enrolled
Andalusian Public Foundation for Health Research in Seville
Spanish Clinical Research Network - SCReN · collabSpanish Network for Research in Infectious Diseases · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized clinical trial to determine the optimal duration of antibiotic treatment for E. Faecalis or E. faecium bacteraemia, following an innovative DOOR / RADAR (Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR)) analysis methodology. Phase IV clinical trial, open-labelled, randomized, pragmatic, multicenter study to demonstrate non-inferiority of a 7-day antibiotic regimen vs. 14 days in the treatment of bacteremia due to E. faecalis or E. faecium.
Timeline
- Start
- 2022-07-11
- Primary completion
- 2024-07-15
- Completion
- 2024-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 875 mg | Intravenous |
| Subject | Amoxicillin | Other / unclassified | 1 g | Intravenous |
| Subject | Ampicillin | Unknown | 2 g | Intravenous |
| Subject | Daptomycin | Other / unclassified | 8 mg/kg | Intravenous |
| Subject | Daptomycin | Other / unclassified | 10 mg/kg | Intravenous |
| Subject | Linezolid | Other / unclassified | 600 mg | Intravenous |
| Subject | Piperacillin | Small molecule | 4 g | Intravenous |
| Subject | Tazobactam | Small molecule | — | Intravenous |
| Subject | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Subject | clavulanic acid | Small molecule | 125 mg | Intravenous |