COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE

Официальное название

COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG-RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE

Обзор

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."

Подробное описание

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.

Вмешательства

• Препарат meropenem
  IV meropenem, 100 mg/kg/day TDS
• Препарат 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

Первичные конечные точки

• 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 [Срок оценки: Time Frame: 10-14days after initiation of treatment]

Критерии участия

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• University of Child Health Scienes Lahore — Lahore

Публикации

• 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

Идентификаторы

NCT: NCT07641348 · (XDR-TYPHOID-RCT-2026 UCHS LH)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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