The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Epicentre
- 入组人数
- 2,412
- 试验地点
- 1
- 主要终点
- Proportion of children discharged from nutritional program as recovered
研究概览
简要总结
This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 6 to 59 months
- •MUAC < 11.5 cm or WHZ < -3
- •Absence of bipedal edema
- •Absence of current illness requiring inpatient care
- •Eligible for new admission for outpatient nutritional therapy for SAM at 3 CRENAS in Madarounfa operated by FORSANI
- •Absence of current clinical illness requiring prescription of specific antibiotic therapy and decision by the study physician to use a specific antimicrobial drug on admission
- •Written consent of parent or caregiver
- •Residence within Niger
排除标准
- •Age < 6 months or > 59 months
- •MUAC ≥ 11.5 cm and WHZ ≥ -3
- •Presence of bipedal edema
- •Presence of current illness requiring inpatient care
- •Decision by the study physician to use a specific different antimicrobial drug on admission
- •Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
- •Treatment with any antibiotic within 7 days
- •Admission to any nutritional program for the treatment of SAM within 3 months
- •Known contraindication / hypersensitivity to amoxicillin
研究组 & 干预措施
Routine antibiotic prescription
Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days)
干预措施: Amoxicillin (Drug)
No routine antibiotic prescription
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of children discharged from nutritional program as recovered
时间窗: Until discharge from the nutritional program, an expected average of 5 weeks
次要结局
- Hospitalization or death(3 months following enrollment)