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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
None posted in the registry

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:
Show all 10Show fewer
  • 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.

Niger1 site

  • Program National de Santé Oculaire

    Niamey

Other trials in Niger

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.

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 groups in NCT04774991
Study groupRoleWhat they receive
Azithro 1-59 fixed pointActive comparatorAzithromycin 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-doorActive comparatorAzithromycin 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.

  1. 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)

  1. Program Costs

    Program costs as captured by routine administrative data collection during the study period and by micro-costing activities

    Measured: 6 months

  2. 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

  3. 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.

  1. First posted1 Mar 2021
  2. Study start28 Jun 2021
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Niger. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Coverage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04774991, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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