drugset / Trial / NCT05199324
Early Oral Switch for Uncomplicated Gram-negative Bacteraemia
Phase 4
Recruiting
720 enrolled
Tan Tock Seng Hospital
American University of Beirut Medical Center · collabChangi General Hospital · collabConsorzio per Valutazioni Biologiche e Farmacologiche · collabGold Coast Hospital and Health Service · collabHospital Sungai Buloh, Selangor · collabHospital del Mar · collabIRCCS Azienda Ospedaliero-Universitaria di Bologna · collabIRCCS San Raffaele · collabIstanbul Medipol University Hospital · collabKPJ Ampang Puteri Specialist Hospital · collabMelbourne Health · collabNational University Hospital, Singapore · collabNg Teng Fong General Hospital · collabPrincess Alexandra Hospital, Brisbane, Australia · collabRambam Health Care Campus · collabSamsung Medical Center · collabSengkang General Hospital · collabSeoul National University Bundang Hospital · collabSheba Medical Center · collabSingapore Clinical Research Institute · collabSingapore General Hospital · collabTaichung Veterans General Hospital · collabUniversiti Kebangsaan Malaysia Medical Centre · collabUniversity Hospital of Patras · collabUniversity Hospital of Pisa · collabUniversity of Malaya · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Current management of uncomplicated Gram-negative bacteraemia entails prolong intravenous (IV) antibiotic therapy with limited evidence to guide oral conversion. This trial aim to evaluate the clinical efficacy and economic impact of early switch to oral antibiotics (within 72 hours from index blood culture collection) versus continuing standard of care IV therapy (for at least another 24 hours post-randomisation) for clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia.
Timeline
- Start
- 2022-06-03
- Primary completion
- 2026-05
- Completion
- 2026-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Subject | Ciprofloxacin | Small molecule | 750 mg | Oral |
| Subject | trimethoprim-sulfamethoxazole | Unknown | 5 mg/kg | Oral |
| Subject | trimethoprim-sulfamethoxazole | Unknown | 160 mg | Oral |
| Subject | trimethoprim-sulfamethoxazole | Unknown | 800 mg | Oral |
| Comparator | Cefazolin | Small molecule | 2 g | Intravenous |
| Comparator | Ceftriaxone | Other / unclassified | 2 g | Intravenous |