Azithromycin for Uncomplicated Severe Acute Malnutrition in Niger (Pilot)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03568643|
Recruitment Status : Not yet recruiting
First Posted : June 25, 2018
Last Update Posted : July 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Uncomplicated Severe Acute Malnutrition||Drug: Azithromycin Drug: Amoxicillin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition: A Individual-randomized Pilot Trial of the Effect of a Single Dose of Oral Azithromycin on Weight Gain in Uncomplicated Severe Acute Malnutrition in Niger|
|Estimated Study Start Date :||June 2020|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Other Name: Zithromax
|Active Comparator: Amoxicillin||
Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Niger guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
- Nutritional recovery [ Time Frame: 8 weeks ]Nutritional recovery is defined as a child having WHZ ≥ -2 on two consecutive visits with MUAC of ≥ 115 mm and no acute complication or edema for the past 7 days.
- Malaria [ Time Frame: 8 weeks ]Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.
- Time to recovery [ Time Frame: 8 weeks ]Time from enrollment to nutritional recovery (defined above) will be recorded.
- Mortality [ Time Frame: 8 weeks ]Vital status will be assessed at all follow-up time points and mortality will be defined as death during the study period.
- Adverse events [ Time Frame: 8 weeks ]Adverse events will be reported at all follow-up time points
- HAZ [ Time Frame: 8 weeks ]Height or length will be measured at all follow-up time points and height-for-age z-scores will be calculated.
- MUAC [ Time Frame: 8 weeks ]Mid-upper arm circumference will be measured at all follow-up time points.
- WAZ [ Time Frame: 8 weeks ]Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated.
- WHZ [ Time Frame: 8 weeks ]Weight and height, assessed at all follow-up time points, will be used to calculate weight-for-height z-scores.
- Weight gain [ Time Frame: 8 weeks ]Weight will be measured at all follow-up time points and weight gain will be defined as grams per kilogram per day (g/kg/day).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568643
|Contact: Kieran S O'Brien, MPHfirstname.lastname@example.org|
|Principal Investigator:||Catherine E Oldenburg, ScD||University of California, San Francisco|