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AVENIR: Azithromycin for Child Survival in Niger
NCT04224987Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2020
- Primary completion
- Jul 2024
- Countries
- 1
- Sponsor
- University of California, San Francisco
- Modality
- Small Molecules
- Drugs
- azithromycin
- Conditions
- child mortality (U5MR)
01
Overview
Phase 4, randomised trial of azithromycin in child mortality (U5MR) (3 arms), sponsored by University of California, San Francisco. Primary endpoints: All-cause Mortality (1-59 Months Old) at 2.5 years, All-cause Mortality (1-11 Months Old) at 2.5 years and 3 more. Started Nov 2020; status: completed.
02
Design
3 arms- Study design
- Randomized
Azithro 1-11
Biannual oral azithromycin to children 1-11 months old and oral placebo to children 12-59 months old
Azithro 1-59
Biannual oral azithromycin to children 1-59 months old
Placebo
Biannual oral placebo to children 1-59 months old
03
Who it enrols
Children aged 1-59 months residing in study communities, with a weight >= 3.0 kg. For sample collections, children 7-12 years and caregivers are also included.
04
Endpoints
Primary
All-cause Mortality (1-59 Months Old)
All-cause Mortality (1-11 Months Old)
All-cause Mortality (12-59 Months Old)
Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)
Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)
Secondary
Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Guardians
Program Costs Per Dose Delivered
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Children Aged 7-12 Years
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