Summary

for people ages 6 months to 59 months (full criteria)
study started
estimated completion:
Catherine E Oldenburg

Description

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 Niger 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 them 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.

Official Title

Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition: A Individual-randomized Pilot Trial of the Effect of a Single Dose of Oral Azithromycin on Weight Gain in Uncomplicated Severe Acute Malnutrition in Niger

Keywords

Uncomplicated Severe Acute Malnutrition Malnutrition Severe Acute Malnutrition Amoxicillin Azithromycin

Eligibility

You can join if…

Open to people ages 6 months to 59 months

  • Age 6-59 months
  • WHZ <-3 SD or MUAC <115 mm
  • Weight >= 3.8 kg
  • 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 CAN'T join if...

  • Age <6 months or >59 months
  • WHZ ≥-3 SD or MUAC ≥115 mm
  • Weight < 3.8 kg
  • 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

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03568643
Phase
Phase 4
Lead Scientist
Catherine E Oldenburg
Study Type
Interventional
Last Updated