Gut and Azithromycin Mechanisms in Infants and Children II
Condition: Malaria
MeSH terms: Malaria
Intervention: Azithromycin; Placebo
Intervention description: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.; Placebo
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Individually randomized placebo-controlled trial of azithromycin vs. placebo to establish the efficacy and safety of azithromycin.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple: (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 449.0
Sex: All
Minimum age: 8 Days
Maximum age: 59 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Childhood mortality is decreasing worldwide. However, many sub-Saharan countries still have
      high children under 5 mortality rates. The MORDOR trial in Niger, Tanzania, and Malawi
      demonstrated a near 14% decrease in all-cause child mortality following biannual azithromycin
      in children 1-59 months. Current trials in Burkina aim to replicate these results from the
      MORDOR study with mass azithromycin treatment.

      The investigators conducted an individually randomized placebo-controlled trial in Burkina
      Faso called the Gut and Azithromycin Mechanisms in Infants and Neonates Trial (GAMIN:
      NCT03676751) to evaluate the effect of a single dose of azithromycin (20 mg/kg) on potential
      mediators of the effect of azithromycin on all-cause mortality and to evaluate changes in the
      gut microbiome longitudinally (results pending). Here, the investigators propose to conduct
      an expansion of the original GAMIN trial. In GAMIN II, the investigators will evaluate 450
      additional 1-59 month old children longitudinally for 6 months with a focus on stool
      collection and malaria status.

      Objectives:

      1. To determine the effect of a single dose of azithromycin for children aged 8 days-59
      months on malaria. The investigators hypothesize that a single dose of azithromycin will
      result in a reduced malaria status within the treatment group compared to the placebo group
      after a 14 day period within children ages 8 days-59 months.

      The study will be conducted in Nouna Town in northwestern Burkina Faso.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 8 days and 59 months old

          -  Primary residence within catchment area of study site

          -  Available for full 6 month study

          -  No known allergy to macrolides/azalides

          -  Appropriate written informed consent from at least one parent or guardian

          -  Able to feed orally

        Exclusion Criteria:

          -  <8 days old or >59 months

          -  Primary residence outside catchment area of study site

          -  Not available for full 6 month study

          -  Known allergy to macrolides/azalides

          -  No written informed consent from at least one parent or guardian

          -  Unable to feed orally