Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
Condition: Uncomplicated Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Intervention: Azithromycin; Amoxicillin
Intervention description: 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.; 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.
Intervention MeSH terms: Amoxicillin; Azithromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 301.0
Sex: All
Minimum age: 6 Months
Maximum age: 59 Months
Healthy volunteers: No

Summary:

      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.
    

Eligibility 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