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

NCT07445282 | Completed Phase 4

• 1 other identifier: 110/SZMC/SZH
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Keywords

XDR Typhoid; Meropenem; Azithromycin; Pediatric; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Time to Defervescence

  Time to defervescence is defined as the number of days from initiation of antibiotic therapy until the axillary body temperature falls below 100°F and remains below this threshold for at least 48 consecutive hours.

  From initiation of antibiotic treatment until achievement of sustained defervescence (up to 14 days)

Study Arms (2)

Meropenem Monotherapy

EXPERIMENTAL

Participants receive intravenous meropenem at a dose of 20-40 mg/kg every 8 hours.

Drug: Meropenem

Meropenem Plus Azithromycin

EXPERIMENTAL

Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day.

Drug: Meropenem; Drug: Azithromycin + Metronidazole

Interventions

Meropenem DRUG

Intravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours.

Meropenem Monotherapy; Meropenem Plus Azithromycin

Azithromycin + Metronidazole DRUG

Participants receive intravenous meropenem (20-40 mg/kg every 8 hours) combined with oral azithromycin at a dose of 20 mg/kg/day.

Meropenem Plus Azithromycin

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 months to under 5 years
• Blood culture-confirmed extensively drug-resistant Salmonella Typhi infection
• Axillary temperature ≥100°F
• Uncomplicated typhoid fever

You may not qualify if:

• Complicated typhoid fever (intestinal perforation, gastrointestinal bleeding, encephalopathy, or shock)
• Known hypersensitivity to meropenem or azithromycin
• Coexisting infections requiring additional antimicrobial therapy
• Chronic conditions including malnutrition or immunodeficiency
• Congenital or acquired heart disease

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Hospital, Rahim Yar Khan, Pakistan

Rahim Yar Khan, Punjab Province, 64200, Pakistan

Location

MeSH Terms

Conditions

Typhoid Fever

Interventions

Meropenem; Azithromycin; Metronidazole

Condition Hierarchy (Ancestors)

Salmonella Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate Resident, Department of Pediatrics

Model Details: Participants were randomly assigned in parallel groups to receive either meropenem monotherapy or meropenem combined with azithromycin.

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: March 3, 2026
• Study Start: May 14, 2025
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

PA (1)