Clinical Trial

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

Study acronym: XDR-TY
Completed Phase 4
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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
Trial Details
NCT Number NCT07445282
Lead Sponsor Sheikh Zayed Medical College
Conditions Extensively Drug-Resistant Typhoid Fever, Typhoid Fever, Salmonella Typhi Infection
Enrollment 90 participants
Start Date 2025-05-14
Primary Completion 2025-11-14 (estimated)
Study Completion 2025-11-14 (estimated)
Updated on ClinicalTrials.gov 2026-03-03