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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03568643
Recruitment Status : Completed
First Posted : June 26, 2018
Results First Posted : September 1, 2022
Last Update Posted : September 1, 2022
Sponsor:
Collaborators:
Centre de Recherche en Sante de Nouna, Burkina Faso
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Uncomplicated Severe Acute Malnutrition Drug: Azithromycin Drug: Amoxicillin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:
Actual Study Start Date : June 3, 2020
Actual Primary Completion Date : December 25, 2020
Actual Study Completion Date : December 25, 2020


Arm Intervention/treatment
Experimental: Azithromycin
children in this arm will receive one dose of azithromycin
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 Name: Zithromax

Active Comparator: Amoxicillin
Children in this arm will receive a 7 day course of amoxicillin (standard of care)
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Burkina Faso
Centre de Recherche en santé de nouna
Nouna, Boucle Du Mouhoun, Burkina Faso
Sponsors and Collaborators
University of California, San Francisco
Centre de Recherche en Sante de Nouna, Burkina Faso
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Catherine E Oldenburg, ScD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03568643    
Other Study ID Numbers: 18-25274
1R21HD100932-01A1 ( U.S. NIH Grant/Contract )
First Posted: June 26, 2018    Key Record Dates
Results First Posted: September 1, 2022
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Nutrition Disorders
Amoxicillin
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents