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

NCT03568643 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 18-252741R21HD100932-01A1
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncomplicated Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

• Weight Gain

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

  8 weeks

Secondary Outcomes (9)

• Nutritional Recovery - Primary Definition

  8 weeks

• Nutritional Recovery - Secondary Definition

  8 weeks

• Malaria

  8 weeks

• Mortality

  8 weeks

• Length/Height-for-age Z-score (LAZ/HAZ)

  8 weeks

Study Arms (2)

Azithromycin

EXPERIMENTAL

children in this arm will receive one dose of azithromycin

Drug: Azithromycin

Amoxicillin

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Interventions

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.

Also known as: Zithromax

Azithromycin

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.

Amoxicillin

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Centre de Recherche en Sante de Nouna, Burkina Faso: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Centre de Recherche en santé de nouna

Nouna, Boucle du Mouhoun, Burkina Faso

Location

Related Publications (4)

• Oldenburg CE, Hinterwirth A, Dah C, Millogo O, Coulibaly B, Ouedraogo M, Sie A, Chen C, Zhong L, Ruder K, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Microbiome among Children with Uncomplicated Severe Acute Malnutrition in a Randomized Controlled Trial of Azithromycin versus Amoxicillin. Am J Trop Med Hyg. 2022 Dec 12;108(1):206-211. doi: 10.4269/ajtmh.22-0381. Print 2023 Jan 11.

  PMID: 36509053 DERIVED

• 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.

  PMID: 35895362 DERIVED

• 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.

  PMID: 34583344 DERIVED

• 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.

  PMID: 33879263 DERIVED

MeSH Terms

Interventions

Azithromycin; Amoxicillin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr Catherine Oldenburg
• Organization: UCSF FI Proctor Foundation

catherine.oldenburg@ucsf.edu

(415) 502-8843

Study Officials

• Catherine E Oldenburg, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: June 3, 2020
• Primary Completion: December 25, 2020
• Study Completion: December 25, 2020
• Last Updated: September 1, 2022
• Results First Posted: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)