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临床试验/NCT05473234
NCT05473234终止3 期

Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2022年10月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
310
试验地点
1
主要终点
Weight Gain at 8 Weeks

研究概览

简要总结

This randomized controlled trial is designed to determine the effect of administration of azithromycin compared to amoxicillin as part of the treatment of uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months on weight gain and nutritional recovery. The investigators will randomize children presenting to Taimaka-run nutritional programs at health centers in Gombe State, Nigeria to a single dose of oral azithromycin or a short course of oral amoxicillin upon admission into the program. Apart from the administration of antibiotics, all children will receive standard outpatient treatment for uncomplicated SAM as specified in the guidelines of the government of Nigeria, which includes therapeutic feeding with ready-to-use therapeutic food (RUTF). Enrolled children will be followed weekly at each routine clinic follow-up visit up until nutritional recovery. All enrolled children will return for a final study visit at 8 weeks following enrollment. Anthropometric and vital status data will be collected at each follow-up visit. Weight gain and nutritional recovery over the 8-week study period will be compared by arm as a primary outcome and at 12 weeks as a secondary outcome.

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
Single (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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Azithromycin

Experimental

Children in this arm will receive one dose of amoxicillin.

干预措施: Azithromycin (Drug)

Amoxicillin

Active Comparator

Children in this arm will receive a 5-day course of amoxicillin (standard care).

干预措施: Amoxicillin (Drug)

结局指标

主要结局

Weight Gain at 8 Weeks

时间窗: 8 weeks

Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/day

次要结局

  • Number of Participants With Nutritional Recovery at 8 Weeks(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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