COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE
COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG-RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Iqra Asghar Ali, mbbs
- 电话号码：+923060942498
- 邮箱：driqraasghar@GMAIL.COM
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、52000
- University of Child Health Scienes Lahore
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接触：
- Iqra Asghar Ali, mbbs
- 电话号码：+923060942498
- 邮箱：driqraasghar@GMAIL.COM
-
首席研究员：
- IQRA Asghar Ali, mbbs
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Meropenem Monotherapy Arm 1
Patients receive meropenem IV, 30mg/kg/dose every 8 hours(maximum 2g per dose)
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IV meropenem, 100 mg/kg/day TDS
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实验性的：Arm 2 Title: Meropenem + Azithromycin Combination
Patients receive meropenem 30mg/kg/dose every 8 hours (maximum 2g per dose) IV plus oral azithromycin, 20 mg/kg/day.
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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
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：Time Frame: 10-14days after initiation of treatment
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Description: Number of days from initiation of appropriate antimicrobial therapy until sustained resolution of fever (<100°F for >48 hours).
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Time Frame: 10-14days after initiation of treatment
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合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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