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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2020-12-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

NCT06010719

Malnutrition, Child Severe Acute Malnutrition

RECRUITING PHASE4

Effectiveness of Oral Antibiotics in the Treatment of Severe Acute Malnutrition

NCT01000298

Kwashiorkor Marasmus

COMPLETED NA

The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications

NCT01613547

Severe Acute Malnutrition

COMPLETED NA

Community Health Azithromycin Trial in Burkina Faso

NCT03676764

Childhood Mortality

COMPLETED PHASE4

Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

NCT01395381

Kwashiorkor Marasmus

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Uncomplicated Severe Acute Malnutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Azithromycin

children in this arm will receive one dose of azithromycin

Group Type EXPERIMENTAL

Azithromycin

Intervention Type 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.

Amoxicillin

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

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zithromax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No