NCT07641348

Brief Summary

This randomized controlled trial will compare the effectiveness of single-drug therapy (meropenem) versus combination therapy (meropenem plus azithromycin) in children aged 2-16 years diagnosed with extensively drug-resistant (XDR) typhoid fever at the Children's Hospital, Lahore. A total of 94 patients will be enrolled and randomly assigned to either treatment group. The primary outcome is time to defervescence, defined as sustained resolution of fever for more than 48 hours. Secondary outcomes include duration of hospital stay and complication rates. The study aims to provide evidence to guide optimal management of XDR typhoid in pediatric populations."

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Jul 2026Feb 2027

First Submitted

Initial submission to the registry

February 26, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

February 26, 2026

Last Update Submit

June 9, 2026

Conditions

Typhoid Fever

Outcome Measures

Primary Outcomes (1)

  • Name: Time to defervescence Description: Number of days from initiation of appropriate antimicrobial therapy until sustained resolution of fever (<100°F for >48 hours). Time Frame: From start of antibiotic therapy upto 10-14 days

    Description: Number of days from initiation of appropriate antimicrobial therapy until sustained resolution of fever (\<100°F for \>48 hours).

    Time Frame: 10-14days after initiation of treatment

Study Arms (2)

Meropenem Monotherapy Arm 1

EXPERIMENTAL

Patients receive meropenem IV, 30mg/kg/dose every 8 hours(maximum 2g per dose)

Drug: meropenem

Arm 2 Title: Meropenem + Azithromycin Combination

EXPERIMENTAL

Patients receive meropenem 30mg/kg/dose every 8 hours (maximum 2g per dose) IV plus oral azithromycin, 20 mg/kg/day.

Drug: Meropenem and azithromycin combination

Interventions

meropenemDRUG

IV meropenem, 100 mg/kg/day TDS

Meropenem Monotherapy Arm 1
Meropenem and azithromycin combinationDRUG

combination drug therapy will consist of meropenem intravenously at a dose of 20-40 mg/kg/dose every 8 hours(maximum 2g per dose) plus azithromycin (orally) at 20 mg/kg/day

Arm 2 Title: Meropenem + Azithromycin Combination

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-16 years
  • Culture-confirmed XDR typhoid fever (resistant to first-line agents, fluoroquinolones, and third-generation cephalosporins)
  • Admitted to Children's Hospital \& Institute of Child Health, Lahore
  • Informed consent obtained from parent/guardian

You may not qualify if:

  • Age \<2 years or \>16 years
  • Known allergy or contraindication to meropenem or azithromycin
  • Presence of severe comorbidities (e.g., congenital heart disease, chronic renal failure, immunodeficiency)
  • Patients already receiving carbapenem or azithromycin therapy prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Child Health Scienes Lahore

Lahore, Punjab Province, 52000, Pakistan

Location

Related Publications (1)

  • Qamar FN, Hussain W, Qureshi S. Salmonellosis Including Enteric Fever. Pediatr Clin North Am. 2022 Feb;69(1):65-77. doi: 10.1016/j.pcl.2021.09.007.

    PMID: 34794677BACKGROUND

Related Links

MeSH Terms

Conditions

Typhoid Fever

Interventions

Meropenem

Condition Hierarchy (Ancestors)

Salmonella InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

ThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Iqra Asghar Ali, mbbs

CONTACT

+923060942498driqraasghar@GMAIL.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Iqra Asghar Ali

Study Record Dates

First Submitted

February 26, 2026

First Posted

June 11, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)