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Completed

NCT Number: NCT03568643

Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

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.

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Key information

Conditions

Uncomplicated Severe Acute Malnutrition

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre de Recherche en santé de nouna

Nouna, Boucle du Mouhoun, Burkina Faso

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

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

Amoxicillin

Drug

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.

Primary outcomes

  1. Weight Gain

    Time frame: 8 weeks

    Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks

Secondary outcomes

  1. Nutritional Recovery - Primary Definition

    Time frame: 8 weeks

    Nutritional recovery is defined as, depending on admission criteria: weight-for-height/length is equal to or more than -2 Z-score and the child have had no oedema for at least 2 weeks, or the mid-upper-arm circumference is equal to or more than 125 mm and the child have had no oedema for at least 2 weeks.

    Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

    Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line

  2. Nutritional Recovery - Secondary Definition

    Time frame: 8 weeks

    Summarize the cumulative proportion recovered by arm. Children are considered recovered if they had mean upper arm circumference > 12.5 or weight-for-height/length > -2 for 2 consecutive measurements. Additionally, it includes children who had had mean upper arm circumference >12.5 or weight-for-height/length > -2 on their final measurement, regardless of whether they met these criteria on the previous visit.

  3. Malaria

    Time frame: 8 weeks

    Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.

  4. 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.

  5. Length/Height-for-age Z-score (LAZ/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.

    A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.

    Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

    Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line

  6. Mid-Upper Arm Circumference (MUAC)

    Time frame: 8 weeks

    Mid-upper arm circumference will be measured at all follow-up time points

  7. Weight-for-Age Z-scores (WAZ)

    Time frame: 8 weeks

    Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated.

    A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.

    Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

    Underweight is weight-for-age below the -2 z-score line. Severely underweight is below the -3 z-score line.

  8. Weight-for-Height Z-score (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.

    A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.

    Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:

    Overweight is weight-for-length/height above the 2 z-score line. Severely overweight; weight-for-length/height above the 3 z-score line

  9. Intestinal Microbiome

    Time frame: Baseline, 8 weeks

    baseline and 8 week intestinal microbiome will be compared between the 2 arms alpha diversity using inverse Simpson's index and Shannon's index, expressed in effective number.

    The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. An index of 0 indicates a community that only has one species. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.

    The Simpson's Diversity Index is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases. The value ranges between 0 and 1, where 1 represents infinite diversity and 0, no diversity.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Centre de Recherche en Sante de Nouna, Burkina Faso
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:

Acronym: SAM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2018
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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