MortalityPhase 4AVENIRNCT04774991
Azithromycin for Child Survival in Niger: Delivery Trial
A Phase 4 study testing Azithromycin for Oral Suspension in people with Mortality and Child Health, run by University of California, San Francisco at 1 site in Niger.
Trial summary
This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to… Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Mortality, Child Health, Implementation
- What is being tested?
- Azithromycin for Oral Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,925 participants
- Where
- 1 siteNiger
- Study dates
- 28 Jun 2021to 30 Jun 2023
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At the community-level, eligibility includes:
- Location in one of the 80 Dosso communities randomly selected for the delivery trial
- Population 250 to 2,499*
- Distance > 5 km from the district headquarters town
- Verbal consent of community leader(s)
- At the individual-level, eligibility includes:
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- Age 1-59 months
- Primary residence in a study community
- Verbal consent of caregiver/guardian for study participation
- Weight ≥ 4 kg
Who cannot join
- At the community-level, eligibility includes:
- Inaccessible or unsafe for study team
- "Quartier" designation on national census *Population size as estimated from the most recent national census or projections
- At the individual-level, eligibility includes:
- Known allergy to macrolides
Trial locations and contacts
1 site in 1 country.
About this study
This cluster-randomized trial aims to compare the impact of different delivery approaches to azithromycin distribution on coverage, costs, and feasibility outcomes. The investigators hypothesize that door-to-door delivery will have higher coverage and costs and similar feasibility and acceptability compared to fixed-point delivery.
Read the detailed description
Azithromycin distribution has been shown to reduce mortality in children 1-59 months. This trial aims to contribute evidence on viable approaches to implementation as high mortality countries consider this intervention to improve child survival. From a pool of eligible rural and peri-urban communities in the Dosso Region in Niger, 80 will be randomly selected and randomized to receive door-to-door or fixed-point delivery of a single dose of azithromycin distribution to children 1-59 months of age via community health workers biannually. Treatment coverage, costs and cost-effectiveness, and feasibility and acceptability will be compared by arm.
- Conditions
- Mortality, Child Health, Implementation
- Being tested
- Azithromycin for Oral Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin for Oral SuspensionDrug
Also called Zithromax
Azithromycin will be administered as a single dose in oral suspension form for children as follows:
- Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
- For children 1 to <12 months of age, weight-based dosing will be used
- For children 12 to 59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.
| Study group | Role | What they receive |
|---|---|---|
| Azithro 1-59 fixed point | Active comparator | Azithromycin distribution to children 1-59 months of age using a fixed-point delivery approach via existing community health workers Receives: Drug: Azithromycin for Oral Suspension |
| Azithro 1-59 door-to-door | Active comparator | Azithromycin distribution to children 1-59 months of age using a door-to-door delivery approach via existing community health workers Receives: Drug: Azithromycin for Oral Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Coverage
Treatment coverage as defined by the number of doses of azithromycin administered in each community divided by the total eligible population
Measured: 6 months
Secondary outcomes (3)
Program Costs
Program costs as captured by routine administrative data collection during the study period and by micro-costing activities
Measured: 6 months
Fidelity of intervention rollout
Fidelity of intervention rollout reported as the percent of protocol steps with complete adherence by the field team
Measured: 6 months
Acceptability of intervention
Participant and provider perception of acceptability of delivery approaches as measured by surveys conducted post-distribution
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start28 Jun 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MortalityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The AVENIR delivery trial is a two-armed, cluster-randomized trial in the Dosso region in Niger. 80 Communities will be randomized in a 1:1 allocation to either door-to-door delivery or fixed-point delivery of azithromycin to children 1-59 months of age.
- Masking
- None (open label)
- Enrolment
- 10,925 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Programme National de Santé Oculaire, Ministère de la Santé Publique du Niger
- Responsible party
- Sponsor
- Investigators
- Tom M Lietman, MD, Principal investigator, University of California, San FranciscoKieran S O'Brien, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774991
- Sponsor's protocol ID
- 19-28387B
- Acronym
- AVENIR
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data underlying outcomes publications will be made publicly available.
Publications
Arzika AM, Maliki R, Amza A, Karamba A, Gallo N, Aichatou B, Sara II, Beidi D, Haroun LM, Oumarou F, Lebas E, Peterson B, Colby E, Nguyen W, Liu Z, Fitzpatrick MC, Arnold BF, Lietman TM, O'Brien KS; AVENIR Study Group. Comparison of door-to-door and fixed-point delivery of azithromycin distribution for child survival in Niger: A cluster-randomized trial. PLOS Glob Public Health. 2023 Nov 15;3(11):e0002559. doi: 10.1371/journal.pgph.0002559. eCollection 2023.
PubMed 37967058