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 (XDR-TY)

February 28, 2026 updated by: Fawad Ahmad, Sheikh Zayed Medical College

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Rahim Yar Khan, Punjab Province, Pakistan, 64200
        • Sheikh Zayed Hospital, Rahim Yar Khan, Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meropenem Monotherapy
Participants receive intravenous meropenem at a dose of 20-40 mg/kg every 8 hours.
Drug: Meropenem
Intravenous meropenem administered at a dose of 20-40 mg/kg every 8 hours.
Experimental: Meropenem Plus Azithromycin
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Defervescence
Time Frame: From initiation of antibiotic treatment until achievement of sustained defervescence (up to 14 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2025

Primary Completion (Actual)

November 14, 2025

Study Completion (Actual)

November 14, 2025

Study Registration Dates

First Submitted

February 21, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110/SZMC/SZH (Other Identifier: Institutional Review Board, Sheikh Zayed Medical College and Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Typhoid Fever

Clinical Trials on Meropenem

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe