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

Enhanced Clinical Recovery With Meropenem-Azithromycin Combination Therapy in Extensively Drug-Resistant Typhoid Feve

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Sheikh Zayed Medical College · Other Government
• Sex: All
• Age: 6 Months – 4 Years
• Healthy volunteers: Not accepted

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

Detailed description

This interventional randomized controlled trial compares intravenous meropenem alone with intravenous meropenem combined with oral azithromycin for the treatment of extensively drug-resistant uncomplicated typhoid fever in children aged 6 months to under 5 years. A total of 90 participants are randomly assigned in equal numbers to receive either meropenem monotherapy or combination therapy. The primary outcome measure is time to defervescence, defined as the time from initiation of antibiotic treatment to reduction of axillary temperature below 100°F maintained for at least 48 consecutive hours. Participants are monitored daily during hospitalization for clinical response and adverse events.

Conditions

• Extensively Drug-Resistant Typhoid Fever
• Typhoid Fever
• Salmonella Typhi Infection

Interventions

Type	Name	Description
DRUG	Meropenem	Intravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours.
DRUG	Azithromycin + Metronidazole	Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day.

Timeline

• Start date: 2025-05-14
• Primary completion: 2025-11-14
• Completion: 2025-11-14
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Pakistan