Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness of azithromycin, an antibiotic, as an additional treatment for children with uncomplicated severe acute malnutrition (SAM). The goal is to see if azithromycin can help these children gain weight and recover better than those receiving a different antibiotic called amoxicillin or a placebo (which is a treatment that looks like the real medication but has no active ingredients). Researchers want to find out if azithromycin can improve the health outcomes of children with SAM, especially since previous studies have had mixed results regarding the benefit of antibiotics in treating this condition.

To be eligible for the trial, children must be between 6 to 59 months old and meet certain health criteria. They should have a specific measure of malnutrition (either a weight-for-height score or a mid-upper arm circumference below certain thresholds) and should not have any serious health conditions or recent antibiotic use. Participants will be enrolled for an 8-week period, during which they will receive either azithromycin, amoxicillin, or a placebo. Parents or guardians will need to provide written consent for their child to take part. This study is important as it could help change treatment guidelines for managing uncomplicated SAM, potentially leading to better health outcomes for affected children.

Gender

ALL

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.