COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: meropenem, Meropenem and azithromycin combination.
- Who it may be relevant to
- Registry conditions: Typhoid Fever. Basic parameters: 2 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG-RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE
Overview
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."
Detailed description
Typhoid fever caused by Salmonella enterica serovar Typhi remains a major public health challenge in low- and middle-income countries. The emergence of extensively drug-resistant (XDR) strains, resistant to first-line agents, fluoroquinolones, and third-generation cephalosporins, has severely limited treatment options. In Pakistan, outbreaks of XDR typhoid have been reported since 2016, with thousands of confirmed cases in Karachi and Hyderabad. Current guidelines recommend carbapenems and azithromycin as the remaining effective agents, but the optimal regimen remains uncertain.
This randomized controlled trial will compare single-drug therapy (meropenem) with combination therapy (meropenem plus azithromycin) in pediatric patients aged 2-16 years with culture-confirmed XDR typhoid fever admitted to the Children's Hospital, Lahore. Ninety-four patients will be enrolled and randomly assigned to either treatment group using concealed allocation. Meropenem will be administered intravenously at 30 mg/kg/dose every 8 hours(maximum 2g per dose)while azithromycin will be given orally at 20 mg/kg/day according to hospital protocol. The primary endpoint is time to defervescence, defined as sustained resolution of fever for more than 48 hours. Secondary endpoints include duration of hospital stay and complication rates.
Interventions
- Drug meropenem
IV meropenem, 100 mg/kg/day TDS - Drug Meropenem and azithromycin combination
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
Primary outcome measures
- 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 [Time frame: Time Frame: 10-14days after initiation of treatment]
Eligibility criteria
- Inclusion Criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- University of Child Health Scienes Lahore — Lahore
Publications
- 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 34794677
Identifiers
NCT: NCT07641348 · (XDR-TYPHOID-RCT-2026 UCHS LH)