~50912 spots leftby Apr 2026

Azithromycin for Pediatric Health

(AVENIR Trial)

WN
EC
EL
SK
Overseen BySandrine Kyane
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: University of California, San Francisco
Must not be taking: Macrolides
Disqualifiers: Allergy to macrolides, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions

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

KO

Kieran O'Brien, PhD, MPH

Principal Investigator

University of California, San Francisco

TL

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

At the community-level: Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
I am between 1-59 months or 7-12 years old, or I am the caregiver of an eligible child.
At the community-level: Verbal consent of community leader(s)
See 5 more

Exclusion Criteria

At the individual-level: Not on list of randomly selected participants from the census
At the community-level: Inaccessible or unsafe for study team
At the individual-level: Known allergy to macrolides
See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers

2 years
Biannual visits for azithromycin distribution

Monitoring

Mortality and antimicrobial resistance monitored through birth histories and community/clinic visit data

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Azithromycin (Macrolide Antibiotic)
Trial OverviewAzithromycin for Oral Suspension is being tested to see if it can reduce child mortality when given twice a year to infants. The study will also monitor the impact on antibiotic resistance within programmatic settings.
Participant Groups
2Treatment groups
Active Control
Group I: Programmatic azithro 1-11Active Control1 Intervention
Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
Group II: no interventionActive Control1 Intervention
No additional intervention.

Azithromycin is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Azithromycin for:
  • 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

Trials
2,636
Recruited
19,080,000+

Bill and Melinda Gates Foundation

Collaborator

Trials
428
Recruited
23,060,000+

Ministry of Health, Niger

Collaborator

Trials
3
Recruited
1,356,000+

Findings from Research

Azithromycin is an effective antibiotic for treating respiratory infections in children, but it should be used cautiously due to concerns about antibiotic resistance, particularly with pneumococcal bacteria.
It is generally not recommended for certain conditions like acute pharyngitis, acute otitis media, or pneumococcal community-acquired pneumonia in children, especially in those at high risk for bacteremia.
Azithromycin use in paediatrics: A practical overview.Ovetchkine, P., Rieder, MJ.[2021]
In a study of 15 pediatric patients aged 1 to 10 years, azithromycin (AZM) demonstrated a high efficacy rate of 92.9% in treating various respiratory tract infections, including pneumonia and bronchitis.
The treatment was generally well-tolerated, with only one case of moderate diarrhea reported, indicating that AZM is a safe option for pediatric patients with respiratory infections.
[Pharmacokinetic and clinical evaluations of azithromycin in the pediatric field].Okada, T., Machida, Y., Fujieda, M., et al.[2016]
Single-dose azithromycin (30 mg/kg) demonstrated a high clinical success rate of 88% in treating children with otitis media, based on data from four clinical trials involving 619 patients.
The treatment was found to be safe, with mostly mild and temporary side effects, and showed excellent compliance rates of 99-100%, making it a suitable alternative for pediatric patients, especially in areas with low macrolide resistance.
Single-dose azithromycin for the treatment of children with acute otitis media.Soley, CA., Arguedas, A.[2006]

References

Azithromycin use in paediatrics: A practical overview. [2021]
[Pharmacokinetic and clinical evaluations of azithromycin in the pediatric field]. [2016]
Single-dose azithromycin for the treatment of children with acute otitis media. [2006]
[Clinical studies on azithromycin in pediatrics]. [2016]
Long-term daily high and low doses of azithromycin in children with cystic fibrosis: a randomized controlled trial. [2010]
Safety of azithromycin in pediatric infectious diseases: a clinical systematic review and meta-analysis. [2022]
Safety profiles and adverse reactions of azithromycin in the treatment of pediatric respiratory diseases: A systematic review and meta-analysis. [2023]
Paediatric safety of azithromycin: worldwide experience. [2019]
Use and safety of azithromycin in neonates: a systematic review. [2022]
[Clinical evaluation of a new macrolide antibiotic, azithromycin, in the pediatric field]. [2016]
Safety of azithromycin in paediatrics: a systematic review protocol. [2023]
[Pharmacokinetic and clinical evaluation of azithromycin in the pediatric field]. [2016]