Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Weight Gain
研究概览
简要总结
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.
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
- 否
入选标准
- •Age 6-59 months
- •WHZ <-3 SD or MUAC <115 mm
- •No nutritional edema
- •Able and willing to participate in full 8-week study
- •Has not been admitted to a nutritional program for the treatment of SAM in the 3 preceeding months
- •No antibiotic use in past 7 days
- •No clinical complications requiring inpatient treatment (except for routine admission for children <6 months)
- •No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
- •No allergy to macrolides/azalides
- •Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
- •Appropriate consent from at least one parent or guardian
排除标准
- •Age <6 months or >59 months
- •WHZ ≥-3 SD or MUAC ≥115 mm
- •Nutritional edema
- •Not able or willing to participate in full 8-week study
- •Admission to a nutritional program for the treatment of SAM in the 3 preceeding months
- •Antibiotic use in past 7 days
- •Clinical complications requiring inpatient treatment
- •Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
- •Allergy to macrolides/azalides
- •Insufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
- •Parent or guardian refuses to provide consent
研究组 & 干预措施
Azithromycin
children in this arm will receive one dose of azithromycin
干预措施: Azithromycin (Drug)
Amoxicillin
Children in this arm will receive a 7 day course of amoxicillin (standard of care)
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Weight Gain
时间窗: 8 weeks
Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks
次要结局
- Nutritional Recovery - Primary Definition(8 weeks)
- Nutritional Recovery - Secondary Definition(8 weeks)
- Malaria(8 weeks)
- Mortality(8 weeks)
- Length/Height-for-age Z-score (LAZ/HAZ)(8 weeks)
- Mid-Upper Arm Circumference (MUAC)(8 weeks)
- Weight-for-Age Z-scores (WAZ)(8 weeks)
- Weight-for-Height Z-score (WHZ)(8 weeks)
- Intestinal Microbiome(Baseline, 8 weeks)