Resistance BacterialPhase 4AVENIRNCT05288023
Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)
A Phase 4 study testing Azithromycin for Oral Suspension in people with Resistance Bacterial and Morality, run by University of California, San Francisco at 1 site in United States.
Trial summary
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Resistance Bacterial, Morality, Child Health
- 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
- 169,707 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 15 Jan 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
- Distinguishable from neighboring communities
- Verbal consent of community leader(s)
- Age 1-11 months
- Primary residence in a study community
- Verbal consent of caregiver/guardian for study participation
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- Location in study region
- Distinguishable from neighboring communities
- Verbal consent of community leader(s)
- Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
- Primary residence in a study community selected for sample collections
- Verbal consent of caregiver/guardian for study participation
Who cannot join
- Inaccessible or unsafe for study team
- "Quartier" designation on national census
- At the individual-level, eligibility includes:
- Known allergy to macrolides
- Population-based sample collections
- At the community-level, eligibility includes:
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- Inaccessible or unsafe for study team
- Included in MORDOR trials
- Not randomly selected
- At the individual-level, eligibility includes:
- Not on list of randomly selected participants from the census
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Programmatic Trial)
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.
Read the detailed description
In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .
All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.
Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.
- Conditions
- Resistance Bacterial, Morality, 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 (up to the maximum adult dose of 1g).
Dosage will be calculated by age for children aged 1-5 months. For children 6-59 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 |
|---|---|---|
| Programmatic azithro 1-11 | Active comparator | Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers Receives: Drug: Azithromycin for Oral Suspension |
| no intervention | No intervention | No additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Genetic Determinants of Macrolide Resistance From Population-based Samples
Prevalence of genetic determinants of macrolide resistance including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus in nasopharyngeal swabs in children aged 1-59 months from population-based samples after 1 year of distribution
Measured: 2 years
Load of Genetic Determinants of Macrolide Resistance From Population-based Samples
Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old from population-based samples, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
Measured: 2 years
Secondary outcomes (3)
Prevalence of Genetic Determinants of Macrolide Resistance From Clinic-based Samples
Prevalence of resistance to macrolides including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus from nasopharyngeal swabs in children 1-59 months old.
Measured: 2 years
Load of Genetic Determinants of Macrolide Resistance From Clinic-based Samples
Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
Measured: 2 years
Number of All-cause Clinic Visits
Number of all-cause clinic visits per month for children aged 1-59 months over 1 year
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Dec 2022
- Primary completion15 Jan 2024
- Study completion15 Jan 2024
Why it stopped: AVENIR I demonstrated efficacy of azithromycin MDA targeted to children 1-59 over 1-11 months in July 2023, thus this trial was stopped before outcomes were collected so Niger could expand the program nationally to include children 1-59 months.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resistance BacterialStudies 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
- Cluster-randomized trial with response adaptive allocation
- Masking
- None (open label)
- Enrolment
- 169,707 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Ministry of Health, Niger
- Responsible party
- Sponsor
- Investigators
- Kieran O'Brien, PhD, MPH, Principal investigator, University of California, San FranciscoTom Lietman, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288023
- Sponsor's protocol ID
- 19-28387C
- Acronym
- AVENIR
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2022
- Last updated
- 28 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data underlying outcomes publications will be made publicly available.
Publications
WHO Guideline on Mass Drug Administration of Azithromycin to Children under Five Years of Age to Promote Child Survival [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK561641/
PubMed 32924384Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474.
PubMed 29694816
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Programmatic Trial)
- ClinicalTrials.gov ID
- NCT05288023
- Acronym / sponsor ID
- AVENIR / 19-28387C
- Conditions
- Resistance Bacterial, Morality, Child Health, Implementation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AVENIR I demonstrated efficacy of azithromycin MDA targeted to children 1-59 over 1-11 months in July 2023, thus this trial was stopped before outcomes were collected so Niger could expand the program nationally to include children 1-59 months.
- Enrolment
- 169,707 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Ministry of Health, Niger
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 28 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.
Detailed description
In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .
All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.
Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized trial with response adaptive allocation
| Arm | Type | Receives |
|---|---|---|
| Programmatic azithro 1-11 | Active comparator | Drug: Azithromycin for Oral SuspensionBiannual oral azithromycin administration to children aged 1-11 months distributed by community health workers |
| no intervention | No intervention | –No additional intervention. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
- Distinguishable from neighboring communities
- Verbal consent of community leader(s)
- Age 1-11 months
- Primary residence in a study community
Key exclusion criteria (11 listed)
- Inaccessible or unsafe for study team
- "Quartier" designation on national census
- Known allergy to macrolides
- Population-based sample collections
- Inaccessible or unsafe for study team
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin for Oral SuspensionAlso: ZithromaxAzithromycin will be administered as a single dose in oral suspension form for children (up to the maximum adult dose of 1g). Dosage will be calculated by age for children aged 1-5 months. For children 6-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program. | Drug | Programmatic azithro 1-11 |
Primary outcome
Prevalence of Genetic Determinants of Macrolide Resistance From Population-based Samples
Time frame: 2 years
Prevalence of genetic determinants of macrolide resistance including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus in nasopharyngeal swabs in children aged 1-59 months from population-based samples after 1 year of distribution
Load of Genetic Determinants of Macrolide Resistance From Population-based Samples
Time frame: 2 years
Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old from population-based samples, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
3 secondary outcomes
Prevalence of Genetic Determinants of Macrolide Resistance From Clinic-based Samples
Time frame: 2 years
Load of Genetic Determinants of Macrolide Resistance From Clinic-based Samples
Time frame: 2 years
Number of All-cause Clinic Visits
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32924384WHO Guideline on Mass Drug Administration of Azithromycin to Children under Five Years of Age to Promote Child Survival [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK561641/
- Background: PubMed 29694816Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474.
- Individual participant dataSharing planned: Yes. De-identified data underlying outcomes publications will be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kieran O'Brien, PhD, MPH principal investigator
University of California, San Francisco
Tom Lietman, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin for Oral Suspension in people with Resistance Bacterial and Morality, run by University of California, San Francisco at 1 site in United States.
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 12 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Prevalence of Genetic Determinants of Macrolide Resistance From Population-based Samples (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT05288023, which also lists 2 linked publications.
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 28 Mar 2025.