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Duration of Antibiotics for the Treatment of Gram-negative Bacilli Bacteremia - a Randomized Controlled Trial
The investigators plan an open label randomized controlled trial to compare short-course antibiotic therapy (\<=7 days) versus longer treatment (\>7 days). The investigators will include hospitalized patients with gram-negative bacteremia. The investigators primary objective is to investigate the safety and efficacy of short-course antibiotics.
Details
| Lead sponsor | Rabin Medical Center |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 604 |
| Start date | 2013-01 |
| Completion | 2018-03-04 |
Conditions
- Gram Negative Bacteremia
Interventions
- short-course antibiotic treatment
- accepted prolonged antibiotic treatment
Primary outcomes
- composite of the following — Until day 90 after randomization
The primary outcome is a composite of the following outcome measures - All -cause mortality — Until day 90 after randomization
All- cause mortality - Treatment Failure — Until day 90 after randomization
Failure including any of the following: 1. Relapse: a recurrent bacteraemia due to the same microorganism occurring from day of randomization and until day 9013 2. Local suppurative complication that was not present at infection onset (e.g. renal abscess in pyelonephritis, empyema in pneumonia) 3. Distant complications of initial infection, defined by growth of the same bacteria as in the initial bacteremia - Hospital re-admissions or extended hospitalization — Until day 90 after randomization
We will define re-admission as a new hospitalization for any cause occurring more than14 days from start of appropriate antibiotic treatment. Patients hospitalized after day 14 (were never discharged or 7-day regimen who were readmitted between days 7-14) will be counted as failures for this outcome. We will define re-admission as a new hospitalization for any cause occurring more than14 days from start of appropriate antibiotic treatment. Patients hospitalized after day 14 (were never discharged or 7-day regimen who were readmitted between days 7-14) will be counted as failures for this outcome.
Countries
Israel, Italy