Clinical trial NCT03568643: Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
Official title: Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uncomplicated Severe Acute Malnutrition
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Sante de Nouna, Burkina Faso
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-06-26
Enrollment: 301
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight Gain
timeFrame: 8 weeks
Secondary outcomes:
measure: Nutritional Recovery - Primary Definition
timeFrame: 8 weeks
measure: Nutritional Recovery - Secondary Definition
timeFrame: 8 weeks
measure: Malaria
timeFrame: 8 weeks
measure: Mortality
timeFrame: 8 weeks
measure: Length/Height-for-age Z-score (LAZ/HAZ)
timeFrame: 8 weeks
measure: Mid-Upper Arm Circumference (MUAC)
timeFrame: 8 weeks
measure: Weight-for-Age Z-scores (WAZ)
timeFrame: 8 weeks
measure: Weight-for-Height Z-score (WHZ)
timeFrame: 8 weeks
measure: Intestinal Microbiome
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Centre de Recherche en santé de nouna
state: Boucle Du Mouhoun
Study officials:
affiliation: University of California, San Francisco
name: Catherine E Oldenburg, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oldenburg CE, Hinterwirth A, Ourohire M, Dah C, Ouedraogo M, Sie A, Boudo V, Chen C, Ruder K, Zhong L, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Resistome after Antibiotics among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2022 Jun 13;107(1):59-64. doi: 10.4269/ajtmh.22-0007. Print 2022 Jul 13.
citation: Sie A, Dah C, Ourohire M, Ouedraogo M, Boudo V, Arzika AM, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Oldenburg CE. Azithromycin versus Amoxicillin and Malarial Parasitemia among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2021 Sep 27;106(1):351-355. doi: 10.4269/ajtmh.21-0595.
citation: O'Brien KS, Sie A, Dah C, Ourohire M, Arzika AM, Boudo V, Lebas E, Godwin WW, Arnold BF, Oldenburg CE. Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):97. doi: 10.1186/s40814-021-00836-w.