drugset / Trial / NCT07445282
This Randomized Controlled Trial Evaluates the Comparative Efficacy of Intravenous Meropenem Alone Versus Intravenous Meropenem Combined With Oral Azithromycin in Children Aged 6 Months to Under 5 Years Diagnosed With Blood Culture-confirmed Extensively Drug-resistant Uncomplicated Typhoid Fever
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized controlled trial evaluates the comparative efficacy of intravenous meropenem alone versus intravenous meropenem combined with oral azithromycin in children aged 6 months to under 5 years diagnosed with blood culture-confirmed extensively drug-resistant uncomplicated typhoid fever. A total of 90 participants are randomly assigned in a 1:1 ratio to receive either meropenem monotherapy or combination therapy. The primary outcome is time to defervescence, defined as the number of days required for body temperature to fall below 100°F and remain so for at least 48 consecutive hours after initiation of antibiotic treatment. Participants are monitored daily during hospitalization for clinical improvement and adverse drug reactions
Timeline
- Start
- 2025-05-14
- Primary completion
- 2025-11-14
- Completion
- 2025-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 20 mg/kg | Oral |
| Subject | Meropenem | Small molecule | 20 mg/kg | Intravenous |
| Subject | Meropenem | Small molecule | 40 mg/kg | Intravenous |
| Subject | Metronidazole | Small molecule | — | — |