NCT06010719 Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
| NCT ID | NCT06010719 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Condition | Malnutrition, Child |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 3,000 participants in total. It began in 2024-10-23 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, the investigators demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, the investigators propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.
Eligibility Criteria
Children with uncomplicated SAM per Burkina Faso's national guidelines who present to an eligible enrollment site during the study period and meet all of the eligibility criteria below will be considered for enrollment: Inclusion criteria: * Age 6-59 months * WHZ\<-3 SD or MUAC\<115 mm * Primary residence within a catchment area of an enrollment site * Available for full 8-week study (primary endpoint) * Not admitted to a nutritional program for SAM treatment in the previous 2 weeks * No edema * No antibiotic use in the past 7 days * No clinical complications requiring antibiotic or inpatient treatment\*\* * 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 known allergies to macrolides/azalides or amoxicillin/penicillin * Sufficient appetite according to a feeding test with RUTF * Written informed consent from at least one parent or guardian Exclusion criteria: * Age less than 6 month or more than 59 months * WHZ\>-3 SD or MUAC\>115 mm * Primary residence is not within a catchment area of an enrollment site * Not Available for full 8-week study (primary endpoint) * Admitted to a nutritional program for SAM treatment in the previous 2 weeks * Edema * Antibiotic use in the past 7 days * Clinical complications requiring antibiotic or 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) * Known allergies to macrolides/azalides or amoxicillin/penicillin * No Sufficient appetite according to a feeding test with RUTF * No Written informed consent from at least one parent or guardian * Per Burkinabé guidelines, children any of the following conditions will not be eligible for the trial and will be referred to an inpatient facility: MUAC \<115 mm with complications; MUAC \<115 mm plus edema; bipedal pitting edema; anorexia or no appetite for RUTF; diarrhea and dehydration; unable to ingest anything without vomiting; severe pneumonia; open cutaneous lesions; hypothermia (35\*C); fever (38.5\*C); paleness suggesting severe anemia; hypoglycemia; very weak, lethargic, or unconscious; convulsions; signs of vitamin A deficiency; or a condition requiring IV infusion or an NG tube.
Contact & Investigator
Catherine Oldenburg, ScD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06010719 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 59 Months, studying Malnutrition, Child. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06010719 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06010719 currently recruiting?
Yes, NCT06010719 is actively recruiting participants. Contact the research team at catherine.oldenburg@ucsf.edu for enrollment information.
Where is the NCT06010719 trial being conducted?
This trial is being conducted at Nouna, Burkina Faso.
Who is sponsoring the NCT06010719 clinical trial?
NCT06010719 is sponsored by University of California, San Francisco. The principal investigator is Catherine Oldenburg, ScD at University of California, San Francisco. The trial plans to enroll 3,000 participants.