Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358872
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-03
Brief Title:
Azithromycin for Child Survival in Niger II
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Azithromycine Pour la Vie Des Enfants au Niger II
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVENIR II
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
Detailed Description:
AVENIR II is a cluster-randomized adaptive platform trial designed to evaluate community health interventions in Niger The initial focus is to monitor under-5 mortality and antimicrobial resistance as the azithromycin MDA for child survival program expands in Niger with the following specific aims
1 Mortality
1 To conduct surveillance of mortality over time compared to the Sustainable Development Goal targets for under-5 mortality reduction As this intervention is not intended to continue indefinitely surveillance against a target is needed to determine when to stop
2 To continue to evaluate the effectiveness of azithromycin MDA to reduce under-5 mortality Given the risk of AMR the effectiveness of the intervention over time is needed to fully weigh the risks against the benefits
2 Antimicrobial Resistance To determine the impact of azithromycin MDA on AMR in population- and clinic-based samples
1 Mortality
1 To conduct surveillance of mortality over time compared to the Sustainable Development Goal targets for under-5 mortality reduction As this intervention is not intended to continue indefinitely surveillance against a target is needed to determine when to stop
2 To continue to evaluate the effectiveness of azithromycin MDA to reduce under-5 mortality Given the risk of AMR the effectiveness of the intervention over time is needed to fully weigh the risks against the benefits
2 Antimicrobial Resistance To determine the impact of azithromycin MDA on AMR in population- and clinic-based samples
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None