Azithromycin for Pediatric Health
(AVENIR Trial)
Trial Summary
What is the purpose of this trial?
This trial tests giving an antibiotic called azithromycin to children aged 1-11 months in areas where many children die. The goal is to see if this reduces deaths by preventing infections. Azithromycin has been shown to reduce child mortality in various trials, particularly in sub-Saharan Africa.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the drug Azithromycin for pediatric health?
Azithromycin has been shown to be effective in treating respiratory infections in children, with a high success rate in conditions like pneumonia and bronchitis. In studies, it was found to be 'markedly effective' in 92.9% of cases and had a clinical success rate of 88% for treating ear infections in children.12345
Is azithromycin safe for children?
Azithromycin is generally safe for children, with most side effects being mild or moderate, such as stomach issues. In studies, about 8.7% of children experienced side effects, which is similar to other antibiotics. Serious side effects are rare, and it can be safely used to treat bacterial infections in children.16789
How is the drug azithromycin unique for treating pediatric conditions?
Azithromycin is unique because it can be given as a single-dose treatment for children with acute otitis media (ear infection), which helps with compliance, especially in areas with low resistance to the drug. It has a long half-life, meaning it stays in the body longer, allowing for less frequent dosing compared to other antibiotics.13101112
Research Team
Kieran O'Brien, PhD, MPH
Principal Investigator
University of California, San Francisco
Tom Lietman, MD
Principal Investigator
University of California, San Francisco
Eligibility Criteria
The trial is for children aged 1-11 months in Niger, specifically from Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions. Caregivers must consent to participation. Children previously in MORDOR trials or with known macrolide allergies cannot join.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
Monitoring
Mortality and antimicrobial resistance monitored through birth histories and community/clinic visit data
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Azithromycin (Macrolide Antibiotic)
Azithromycin is already approved in Canada for the following indications:
- Respiratory tract infections
- Skin and soft tissue infections
- Sexually transmitted diseases
- Toxoplasmosis
- Malaria
- Preterm prelabor rupture of membranes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Bill and Melinda Gates Foundation
Collaborator
Ministry of Health, Niger
Collaborator