Child MortalityPhase 4MIRAMANCT04716712
Infant Mortality Reduction by the Mass Administration of Azithromycin
A Phase 4 study testing Azithromycin in people with Child Mortality, run by University of California, San Francisco at 3 sites in 2 countries.
Trial summary
This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months… Read more about this study
- Who is it for?
- Ages 1 month to 11 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Mortality
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 694,400 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Oct 2021to 30 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 11 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Community eligibility criteria:
- Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins
- Verbal consent of the community leader is obtained
- Aged 1 to 11 months
- Living in one of the communities participating in the study
Who cannot join
- Community exclusion criteria:
- Inaccessible or unsafe for the study team
- Known allergy to macrolides
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Burkina Faso2 sites
Centre de Recherche en Sante de Nouna
Nouna
Helen Keller International
Ouagadougou
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine
This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.
Read the detailed description
The MORDOR clinical trial funded by the Bill \& Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months.
In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations.
Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.
- Conditions
- Child Mortality
- Being tested
- Azithromycin, Placebo
- Keywords
- Azithromycin, Mass Drug Administration, Child Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
Azithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months.
PlaceboDrug
Matching identical placebo in packaging, appearance, and taste.
| Study group | Role | What they receive |
|---|---|---|
| Biannual mass oral azithromycin + child health days | Active comparator | Bi-annual Mass Azithromycin distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform Receives: Drug: Azithromycin |
| Biannual mass placebo + child health days | Placebo comparator | Bi-annual Mass placebo distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform Receives: Drug: Placebo |
| Resistance Sub Study: Azithromycin + Child Health Days | Active comparator | Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion Receives: Drug: Azithromycin |
| Resistance Sub Study: Placebo + Child Health Days | Placebo comparator | Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
- Evaluate whether azithromycin integrated within the VAD+ platform reduces mortality in children aged 1-11 months old compared to placebo
Measured: 24 months following baseline
Secondary outcomes (2)
Antimicrobial Resistance (AMR)
- To compare the cluster level load of genetic determinants of macrolides resistance in rectal samples collected from children 1-59 months old in the clusters receiving azithromycin compared to the clusters receiving placebo
Measured: 24 months
Clinic Visits
- Evaluate whether azithromycin integrated within the VAD+ platform changes the rate of clinic visits in children aged 1-11 month old compared to placebo.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start4 Oct 2021
- Primary completion30 Jan 2025
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The study will be a double-blind, placebo-controlled, cluster-randomized trial in which health centers (CSPS) in the 3 intervention regions will be randomized to either CHD combined with placebo (33%) or CHD combined with Azithromycin (67%), an allocation of 1:2 that favors active treatment. The allocation sequence and treatment labels will be masked to all but one biostatistician and one analyst at UCSF. The placebo will be indistinguishable from the active azithromycin. Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion to CHD+placebo or CHD+azithromycin
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 694,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International, Centre de Recherche en Sante de Nouna, Burkina Faso, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Thomas Lietman, MD, Principal investigator, University of California, San FranciscoGeorges Dimithe, Study director, Helen Keller International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716712
- Sponsor's protocol ID
- 20-32979
- Acronym
- MIRAMA
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keenan 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 29694816Yago-Wienne F, Toure D, Dimithe G, Khassanova R, Sidibe S, Some PN, Bamba I, Zombre V, Sie A, Bountogo M, Coulibaly B, Ouattara M, Peterson B, Arnold B, Lietman TM, Lebas E, O'Brien KS. Integration of azithromycin mass administration to 1-11-month-old children into an existing health platform to reduce child mortality: a cluster-randomised trial in Burkina Faso. BMJ Glob Health. 2026 Jan 8;11(1):e021336. doi: 10.1136/bmjgh-2025-021336.
PubMed 41506755
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine
- ClinicalTrials.gov ID
- NCT04716712
- Acronym / sponsor ID
- MIRAMA / 20-32979
- Conditions
- Child Mortality
- Keywords
- Azithromycin, Mass Drug Administration, Child Mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 694,400 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Helen Keller International, Centre de Recherche en Sante de Nouna, Burkina Faso, Bill and Melinda Gates Foundation
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.
Detailed description
The MORDOR clinical trial funded by the Bill \& Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months.
In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations.
Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The study will be a double-blind, placebo-controlled, cluster-randomized trial in which health centers (CSPS) in the 3 intervention regions will be randomized to either CHD combined with placebo (33%) or CHD combined with Azithromycin (67%), an allocation of 1:2 that favors active treatment. The allocation sequence and treatment labels will be masked to all but one biostatistician and one analyst at UCSF. The placebo will be indistinguishable from the active azithromycin. Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion to CHD+placebo or CHD+azithromycin
| Arm | Type | Receives |
|---|---|---|
| Biannual mass oral azithromycin + child health days | Active comparator | Drug: AzithromycinBi-annual Mass Azithromycin distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform |
| Biannual mass placebo + child health days | Placebo comparator | Drug: PlaceboBi-annual Mass placebo distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform |
| Resistance Sub Study: Azithromycin + Child Health Days | Active comparator | Drug: AzithromycinAntimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion |
| Resistance Sub Study: Placebo + Child Health Days | Placebo comparator | Drug: PlaceboAntimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion |
Who may qualify
- Ages
- 1 month to 11 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins
- Verbal consent of the community leader is obtained
- Aged 1 to 11 months
- Living in one of the communities participating in the study
Key exclusion criteria (3 listed)
- Inaccessible or unsafe for the study team
- Known allergy to macrolides
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 |
|---|---|---|
| AzithromycinAlso: ZithromaxAzithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months. | Drug | Biannual mass oral azithromycin + child health days, Resistance Sub Study: Azithromycin + Child Health Days |
| PlaceboMatching identical placebo in packaging, appearance, and taste. | Drug | Biannual mass placebo + child health days, Resistance Sub Study: Placebo + Child Health Days |
Primary outcome
All-cause mortality
Time frame: 24 months following baseline
a) Evaluate whether azithromycin integrated within the VAD+ platform reduces mortality in children aged 1-11 months old compared to placebo
2 secondary outcomes
Antimicrobial Resistance (AMR)
Time frame: 24 months
Clinic Visits
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- 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.
- Derived from this study: PubMed 41506755Yago-Wienne F, Toure D, Dimithe G, Khassanova R, Sidibe S, Some PN, Bamba I, Zombre V, Sie A, Bountogo M, Coulibaly B, Ouattara M, Peterson B, Arnold B, Lietman TM, Lebas E, O'Brien KS. Integration of azithromycin mass administration to 1-11-month-old children into an existing health platform to reduce child mortality: a cluster-randomised trial in Burkina Faso. BMJ Glob Health. 2026 Jan 8;11(1):e021336. doi: 10.1136/bmjgh-2025-021336.
- Individual participant dataSharing planned: No
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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.
Thomas Lietman, MD principal investigator
University of California, San Francisco
Georges Dimithe study director
Helen Keller International
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin in people with Child Mortality, run by University of California, San Francisco at 3 sites in 2 countries.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 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 3 sites in Burkina Faso, 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
All-cause mortality (time frame: 24 months following baseline). 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 NCT04716712, 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 13 Mar 2025.