Enhanced Clinical Recovery With Meropenem-Azithromycin Combination Therapy in Extensively Drug-Resistant Typhoid Feve
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to Defervescence
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months to under 5 years
- •Blood culture-confirmed extensively drug-resistant Salmonella Typhi infection
- •Axillary temperature ≥100°F
- •Uncomplicated typhoid fever
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Meropenem (Drug)
Meropenem Monotherapy
Participants receive intravenous meropenem at a dose of 20-40 mg/kg every 8 hours.
干预措施: Meropenem (Drug)
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.
干预措施: Azithromycin + Metronidazole (Drug)
结局指标
主要结局
Time to Defervescence
时间窗: 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.
次要结局
未报告次要终点
研究者
Fawad Ahmad
Postgraduate Resident, Department of Pediatrics
Sheikh Zayed Medical College