Title

Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    301
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.
Study Started
Jun 03
2020
Primary Completion
Dec 25
2020
Study Completion
Dec 25
2020
Last Update
Aug 11
2021

Drug Azithromycin

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 names: Zithromax

Drug 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 Burkina Faso 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.

Azithromycin Experimental

children in this arm will receive one dose of azithromycin

Amoxicillin Active Comparator

Children in this arm will receive a 7 day course of amoxicillin (standard of care)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted