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临床试验/NCT03370003
NCT03370003已完成不适用

Operational Experience With Non-routine Use of Antibiotics in the Treatment of Severe Uncomplicated Acute Malnutrition in Children

Epicentre0 个研究点目标入组 2,876 人开始时间: 2016年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Epicentre
入组人数
2,876
主要终点
Evaluation of nutritional recovery

研究概览

简要总结

To evaluate, in routine operational settings of treatment of uncomplicated Severe Acute Malnutrition (SAM) in children aged 6-59 months, the risk of nutritional recovery and hospitalization with non-routine use of amoxicillin compared to the risk achieved with systematic use of antibiotics.

详细描述

Upon admission, all children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics. Antibiotics will be provided at admission and during follow-up only if clinically justified. The results of the program (ie, nutritional recovery, hospitalization, death and abandonment) will be monitored in all children aged 6 to 59 months admitted for outpatient therapy in 2 outpatient treatment sites in the Madarounfa health district in Niger.

To ensure that the children included in the study receive appropriate care, the study will ask the children's leaders to return to the clinic for medical surveillance in the event of a clinical complication. Program staff will facilitate appropriate management, including prescription of antibiotics if clinically justified, and transfer to hospital of all children in need of close supervision and / or comprehensive medical management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
6 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age 6-59 months
  • Direct admission for the treatment of uncomplicated SAM (MUAC <115 mm or PTZ <-3 and / or presence of Grade + or ++ nutritional edema and moderate or good appetite with absence of medical complications)
  • Signed Informed Consent

排除标准

  • No Informed Consent given
  • Not directly admitted for the treatment of uncomplicated SAM at the CRENAS (Center for Outpatient Nutritional Rehabilitation for Malnutrition) of the study

结局指标

主要结局

Evaluation of nutritional recovery

时间窗: Through study participation, no more than 2 months after follow-up of the last participant

Primary outcome will be measured in the field of nutrition, hospitalization, death and abandonment in the observation site (s) with that observed in 3 comparison groups: 1. Children receiving amoxicillin and placebo in the randomized trial conducted by MSF (2012-2014) 2. Children receiving amoxicillin in MSF program sites not selected for study in Madarounfa (2016) 3. Children receiving amoxicillin at selected sites from the previous year (2015)

次要结局

未报告次要终点

研究者

发起方
Epicentre
申办方类型
Other
责任方
Sponsor

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