NCT06358872 Azithromycin for Child Survival in Niger II
| NCT ID | NCT06358872 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Condition | Mortality |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,300,000 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2028-04-29 |
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 3,300,000 participants in total. It began in 2024-04-29 with a primary completion date of 2028-04-29.
⚠ 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
Several randomized controlled trials have demonstrated that azithromycin mass drug administration (MDA) reduces child mortality, but increases antimicrobial resistance (AMR). The World Health Organization (WHO) guidelines for this intervention specify that implementation must be accompanied by continued monitoring of mortality and AMR. Niger is expanding the azithromycin MDA program nationwide. To establish monitoring of mortality and AMR as part of this program as well as to leverage the infrastructure to evaluate other child health interventions, AVENIR II is designed as an adaptive platform trial with monitoring and re-randomization every 2 years.
Eligibility Criteria
Inclusion Criteria: CSI-level for mortality and AMR monitoring: * Located in a region participating in the program * Designated as rural by local study team * Selected for participation in monitoring activities * Safe and accessible for study teams * Verbal approval from community leaders Individual level for mortality monitoring: * Residing in the catchment area of an eligible CSI * Selected for participation in monitoring activities * Female * Age between 12 and 55 years old * Verbal approval from participant Individual-level for AMR monitoring: * Residing in the catchment area of an eligible CSI * Selected for participation in monitoring activities * Age between 1 and 59 months old * Verbal approval from a caregiver or guardian Exclusion Criteria: At the community-level: * Designated as urban by local study team * Inaccessible or unsafe for study team At the individual-level: * Known allergy to macrolides
Contact & Investigator
Kieran S O'Brien, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06358872 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 59 Months, studying Mortality. 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 NCT06358872 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 NCT06358872 currently recruiting?
Yes, NCT06358872 is actively recruiting participants. Contact the research team at andrea.picariello@ucsf.edu for enrollment information.
Where is the NCT06358872 trial being conducted?
This trial is being conducted at Niamey, Niger.
Who is sponsoring the NCT06358872 clinical trial?
NCT06358872 is sponsored by University of California, San Francisco. The principal investigator is Kieran S O'Brien, PhD at University of California, San Francisco. The trial plans to enroll 3,300,000 participants.