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CompletedNCT04224987AVENIRUpdated Aug 6, 2026Results posted

Azithromycin for Child Survival in Niger: Mortality and Resistance Trial

A Phase 4 interventional study of Azithromycin and Placebo in Mortality, Resistance Bacterial and Child, Only, sponsored by University of California, San Francisco. Completed at 1 site in Niger. Open to participants aged 1 Month to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
864,493
Allocation
Randomized
Ages
1 Month to 59 Months
Sex
All
01

Study 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.Targeting treatment to children 1-11 months old could reduce antimicrobial resistance by limiting antibiotic distributions while treating children at the highest mortality risk. However, this targeted intervention has not yet been tested.

The AVENIR mortality/resistance trial aims to assess the efficacy of age-based targeting of biannual azithromycin distribution on mortality as well as determine the impact of age-based targeting on antimicrobial resistance.

Read the detailed description

In the Mortality/Resistance trial, 3,000 communities in the Dosso and Tahoua regions of Niger will be randomized to one of three arms: 1) azithro 1-11: biannual oral azithromycin to children 1-11 months old with biannual oral placebo to children 12-59 months old, 2) azithro 1-59: biannual oral azithromycin to children 1-59 months old, or 3) placebo: biannual oral placebo to children 1-59 months old. Interventions will be delivered biannually through a door-to-door census. Mortality will also be monitored through biannual census data collection, which will be used to adaptively allocate treatment assignments after the first year. Communities will retain an allocation for 4 distributions before being re-randomized.

Antimicrobial resistance will be monitored using cluster sampling of treated and untreated children and adults in the Dosso region.

To compare costs, coverage, and acceptability of treating 1-11-month-old children only vs children 1-59 months old, an additional 80 communities in the Dosso region will be selected. These communities will be randomized in a 1:1 fashion to either receive 1) distribution of open-label azithromycin to children 1-11 months old with no intervention to children 12-59 months old or 2) distribution of open-label azithromycin to children 1-59 months old. The primary outcome for this substudy will be community-level costs per dose delivered. Secondary outcomes include program costs, treatment coverage, and acceptability of the intervention according to community leaders, community health workers, and caregivers of eligible children.

02

Conditions studied

  • Mortality
  • Resistance Bacterial
  • Child, Only

Keywords

  • Mass Treatment
  • Azithromycin
  • Childhood Mortality Rate
  • Antimicrobial Resistance
  • Implementation and Cost Analysis
03

In context

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Browse University of California, San Francisco studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 59 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  1. Intervention

    At the community-level, eligibility includes:

    Inclusion Criteria:

    • Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
    • Population 250 to 2,499*
    • Distance > 5 km from district headquarters town
    • Distinguishable from neighboring communities
    • Verbal consent of community leader(s)

    Exclusion criteria:

    • 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:

    Inclusion criteria:

    • Age 1-59 months
    • Primary residence in a study community
    • Verbal consent of caregiver/guardian for study participation
    • Weight ≥ 3.0 kg (*no weight limits in communities using age-based dosing)

    Exclusion criteria:

    • Known allergy to macrolides
  2. Population-based sample collections

At the community-level, eligibility includes:

Inclusion Criteria:

  • Location in Dosso
  • Distinguishable from neighboring communities
  • Verbal consent of community leader(s)

Exclusion criteria:

  • Inaccessible or unsafe for the study team
  • Included in MORDOR trials
  • Not randomly selected
  • Received treatment prior to sample collection

At the individual-level, eligibility includes:

Inclusion Criteria:

  • 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

Exclusion criteria:

  • An individual is not on the list of randomly selected participants from the census
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
864,493 participants (actual)

Study arms

  • Active comparator
    Azithro 1-11

    Biannual weight- or height-based dose of oral azithromycin suspension to children 1-11 months old and oral placebo or no intervention to children 12-59 months old

    Drug: Azithromycin · Other: Placebo

  • Active comparator
    Azithro 1-59

    Biannual age, weight- or height-based dose of oral azithromycin suspension to children 1-59 months old

    Drug: Azithromycin

  • Placebo comparator
    Placebo

    Biannual weight- or height-based dose of oral placebo to children 1-59 months old

    Other: Placebo

Interventions

  • DrugAzithromycin

    Azithromycin will be administered as a directly observed dose in oral suspension form for children: 1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) 2. For children 1-11 months of age, weight or age-based dosing will be used 3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program

    Also known as: Zithromax

  • OtherPlacebo

    Placebo will be administered as a directly observed dose in oral suspension form for children: 1. Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) 2. For children 1-11 months of age, weight-based dosing will be used 3. For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program

06

What researchers measure

Primary outcomes

  1. All-cause Mortality (1-59 Months Old)

    Mortality rate (deaths per 1,000 person-years at risk) among children 1-59 months of age, comparing the azithro 1-59 and placebo arms.

    Time frame: from 6 months up to 2.5 years

  2. All-cause Mortality (1-11 Months Old)

    Mortality rate (deaths per 1,000 person-years at risk) among children 1-11 months of age, comparing the azithro 1-11 and placebo arms.

    Time frame: from 6 months up to 2.5 years

  3. All-cause Mortality (12-59 Months Old)

    Mortality rate (deaths per 1,000 person-years at risk) among children 12-59 months of age with rates compared between azithro 1-11 and azithro 1-59 communities.

    Time frame: from 6 months up to 2.5 years

  4. Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)

    Prevalence of macrolide resistance among pneumococcus-positive nasopharyngeal swabs collected from children aged 1-59 months after 4 distributions. Resistance was assessed among culture-positive pneumococcal isolates from nasopharyngeal swabs.

    Time frame: After 4 distributions (approximately 24 months)

  5. Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)

    Community-level load of macrolide antimicrobial resistance determinants in pooled rectal swabs collected from children aged 1-59 months after four biannual distributions. Rectal swabs from each community were pooled and analyzed using metagenomic DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts.

    Time frame: After 4 distributions (approximately 24 months)

Secondary outcomes

  1. Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months

    All-cause mortality incidence rate among children aged 1-11 months who had weight measured during at least one census round and had a valid weight-for-age z-score calculated using the World Health Organization Child Growth Standards. Nutritional status was assessed at the beginning of each census interval. This measure reports the overall mortality rate for this analysis population by randomized treatment arm and is not stratified by weight-for-age z-score subgroup. Mortality rates are reported as deaths per 1,000 person-years.

    Time frame: After 4 distributions (approximatively 24 month after first distribution)

  2. Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Guardians

    Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from guardians of children eligible for treatment after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.

    Time frame: After 4 distributions (approximatively 24 month after first distribution)

  3. Program Costs Per Dose Delivered

    Program cost per dose delivered was estimated using routine administrative data and micro-costing activities. Costs were calculated per dose delivered and were not stratified by randomized treatment arm.

    Time frame: 1 year

  4. Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Children Aged 7-12 Years

    Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from children aged 7-12 years after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.

    Time frame: After 4 distributions, approximately 24 months

07

Results

Posted May 14, 2025

Participant flow

Participant flow — Overall Study
MilestoneAzithro 1-11Azithro 1-59Placebo
Started245227334446284820
Completed245227334446284820
Not completed000

Outcome measures

PrimaryAll-cause Mortality (1-59 Months Old)

Mortality rate (deaths per 1,000 person-years at risk) among children 1-59 months of age, comparing the azithro 1-59 and placebo arms.

Time frame:
from 6 months up to 2.5 years
Reported as:
Number · deaths per 1,000 person-years
All-cause Mortality (1-59 Months Old)
deaths per 1,000 person-yearsAzithro 1-11Azithro 1-59Placebo
All-cause Mortality (1-59 Months Old)13.8 (12.9 to 14.8)11.9 (11.3 to 12.6)13.9 (13.0 to 14.8)
PrimaryAll-cause Mortality (1-11 Months Old)

Mortality rate (deaths per 1,000 person-years at risk) among children 1-11 months of age, comparing the azithro 1-11 and placebo arms.

Time frame:
from 6 months up to 2.5 years
Reported as:
Number · deaths per 1,000 person years
All-cause Mortality (1-11 Months Old)
deaths per 1,000 person yearsAzithro 1-11Azithro 1-59Placebo
All-cause Mortality (1-11 Months Old)22.3 (10.0 to 24.7)18.5 (16.7 to 20.4)23.9 (21.6 to 26.2)
PrimaryAll-cause Mortality (12-59 Months Old)

Mortality rate (deaths per 1,000 person-years at risk) among children 12-59 months of age with rates compared between azithro 1-11 and azithro 1-59 communities.

Time frame:
from 6 months up to 2.5 years
Reported as:
Number · deaths per 1,000 person-years
All-cause Mortality (12-59 Months Old)
deaths per 1,000 person-yearsAzithro 1-11Azithro 1-59Placebo
All-cause Mortality (12-59 Months Old)12.2 (11.3 to 13.1)10.7 (10.0 to 11.4)12.0 (11.2 to 13.0)
PrimaryPrevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)

Prevalence of macrolide resistance among pneumococcus-positive nasopharyngeal swabs collected from children aged 1-59 months after 4 distributions. Resistance was assessed among culture-positive pneumococcal isolates from nasopharyngeal swabs.

Time frame:
After 4 distributions (approximately 24 months)
Reported as:
Number · macrolide-resistant pneumococcal isolate
Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)
macrolide-resistant pneumococcal isolateAzithro 1-11Azithro 1-59Placebo
Prevalence of Resistance to Macrolides - Nasopharyngeal Swabs (1-59 Months Old)128130127
PrimaryLoad of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)

Community-level load of macrolide antimicrobial resistance determinants in pooled rectal swabs collected from children aged 1-59 months after four biannual distributions. Rectal swabs from each community were pooled and analyzed using metagenomic DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts.

Time frame:
After 4 distributions (approximately 24 months)
Reported as:
Mean · Matched resistance reads per million non
Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)
Matched resistance reads per million nonAzithro 1-11Azithro 1-59Placebo
Load of Genetic Determinants of Resistance to Macrolides - Rectal Swabs (1-59 Months Old)130.70 ± 34.31415.59 ± 31.36125.77 ± 30.70
SecondaryMortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months

All-cause mortality incidence rate among children aged 1-11 months who had weight measured during at least one census round and had a valid weight-for-age z-score calculated using the World Health Organization Child Growth Standards. Nutritional status was assessed at the beginning of each census interval. This measure reports the overall mortality rate for this analysis population by randomized treatment arm and is not stratified by weight-for-age z-score subgroup. Mortality rates are reported as deaths per 1,000 person-years.

Time frame:
After 4 distributions (approximatively 24 month after first distribution)
Reported as:
Number · deaths per 1,000 person-years
Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months
deaths per 1,000 person-yearsAzithro 1-11Azithro 1-59Placebo
Mortality Rate by Weight-for-age Z-score Subgroup Among Infants Aged 1-11 Months22.5 (20 to 25.2)18.1 (15.9 to 20.1)24 (21.4 to 26.6)
SecondaryLoad of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Guardians

Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from guardians of children eligible for treatment after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.

Time frame:
After 4 distributions (approximatively 24 month after first distribution)
Reported as:
Mean · Matched resistance reads per million non
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Guardians
Matched resistance reads per million nonAzithro 1-11Azithro 1-59Placebo
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Guardians1.85 ± 6.945.55 ± 13.715.66 ± 18.71
SecondaryProgram Costs Per Dose Delivered

Program cost per dose delivered was estimated using routine administrative data and micro-costing activities. Costs were calculated per dose delivered and were not stratified by randomized treatment arm.

Time frame:
1 year
Reported as:
Number · US dollars per dose delivered
Program Costs Per Dose Delivered
US dollars per dose deliveredOverall Program - All Arms
Program Costs Per Dose Delivered1.59
SecondaryLoad of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Children Aged 7-12 Years

Community-level loads of macrolide antimicrobial resistance determinants in nasopharyngeal swabs collected from children aged 7-12 years after four biannual distributions. Nasopharyngeal swabs from each community were pooled and analyzed using DNA sequencing. Nonhost sequencing reads were aligned to an antimicrobial resistance reference database, and reads matching macrolide resistance determinants were summed and normalized to the total number of nonhost reads in the pooled sample. Values are reported as matched resistance reads per million nonhost reads (rM). Higher values indicate a greater abundance of macrolide resistance determinants. The values presented in the table are untransformed normalized counts; log-transformed values were used only for inferential statistical analyses.

Time frame:
After 4 distributions, approximately 24 months
Reported as:
Mean · Matched resistance reads per million non
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Children Aged 7-12 Years
Matched resistance reads per million nonAzithro 1-11Azithro 1-59Placebo
Load of Genetic Determinants of Resistance to Macrolides in Nasopharyngeal Swabs From Children Aged 7-12 Years0.86 ± 3.274.45 ± 11.500.25 ± 0.87

Adverse events

Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Azithro 1-111,666/104,374 (1.6%)1/104,374 (0%)0/104,374 (0%)
Azithro 1-591,914/153,626 (1.2%)1/153,626 (0%)0/153,626 (0%)
Placebo1,923/124,617 (1.5%)3/124,617 (0%)0/124,617 (0%)
Most frequent serious events
Most frequent serious events
EventAzithro 1-11Azithro 1-59Placebo
hospitalization for malariaGeneral disorders0/1043740/1536262/124617
Malaria, fever, diarrhea, vomitingGeneral disorders1/1043740/1536260/124617
hospitalization for vomiting, diarrhea, and feverGastrointestinal disorders0/1043740/1536261/124617
diarrhea, fever and vomitingGastrointestinal disorders0/1043741/1536260/124617

Baseline characteristics

Age, Customized
Age, Customized(Participants)Azithro 1-11Azithro 1-59PlaceboTotal
Age in months categorical — 1-11 months75698220798123770
Age in months categorical — 12-23 months84528922877326147
Age in months categorical — 24-59 months25043272702694879261
Sex: Female, Male
Sex: Female, Male(Participants)Azithro 1-11Azithro 1-59PlaceboTotal
Female20605220782158264265
Male20459223342212064913
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Azithro 1-11Azithro 1-59PlaceboTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American410644441243702129178
White0000
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Azithro 1-11Azithro 1-59PlaceboTotal
Niger410644441243702129178
Children per community
Children per community(children per community)Azithro 1-11Azithro 1-59PlaceboTotal
Mean95.28 ± 71.3695.92 ± 67.4894.39 ± 61.6595.19 ± 66.79
08

Study locations

1 site
  • Programme national de santé oculaire
    Niamey, Niger
09

References and documents

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 29694816 ↗
  • Doan T, Arzika AM, Hinterwirth A, Maliki R, Zhong L, Cummings S, Sarkar S, Chen C, Porco TC, Keenan JD, Lietman TM; MORDOR Study Group. Macrolide Resistance in MORDOR I - A Cluster-Randomized Trial in Niger. N Engl J Med. 2019 Jun 6;380(23):2271-2273. doi: 10.1056/NEJMc1901535. No abstract available. PubMed 31167060 ↗
  • Keenan JD, Arzika AM, Maliki R, Boubacar N, Elh Adamou S, Moussa Ali M, Cook C, Lebas E, Lin Y, Ray KJ, O'Brien KS, Doan T, Oldenburg CE, Callahan EK, Emerson PM, Porco TC, Lietman TM. Longer-Term Assessment of Azithromycin for Reducing Childhood Mortality in Africa. N Engl J Med. 2019 Jun 6;380(23):2207-2214. doi: 10.1056/NEJMoa1817213. PubMed 31167050 ↗
  • 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 32924384 ↗
  • Oldenburg CE, Arzika AM, Maliki R, Lin Y, O'Brien KS, Keenan JD, Lietman TM, For The Mordor Study Group. Optimizing the Number of Child Deaths Averted with Mass Azithromycin Distribution. Am J Trop Med Hyg. 2020 Sep;103(3):1308-1310. doi: 10.4269/ajtmh.19-0328. PubMed 32067626 ↗
  • Peterson B, Arzika AM, Maliki R, Amza A, Aichatou B, Bello IM, Beidi D, Galo N, Harouna N, Karamba AM, Mahamadou S, Abarchi M, Ibrahim A, Lebas E, Liu Z, Brandt C, Colby E, Oldenburg CE, Porco TC, Arnold BF, Lietman TM, O'Brien KS. Predictors of home- vs. facility-based delivery among women living in rural Niger: a cross-sectional survey within the AVENIR cluster-randomised trial. J Glob Health. 2026 May 22;16:04167. doi: 10.7189/jogh.16.04167. PubMed 42170714 ↗
  • Doan T, Yan D, Arzika AM, Abdou A, Maliki R, Aichatou B, Bello IM, Beidi D, Galo N, Harouna N, Karamba AM, Mahamadou S, Abarchi M, Ibrahim A, Zhong L, Chen C, Liu Y, Yu D, Abraham T, Cheng AS, Peterson B, Oldenburg CE, Porco TC, Arnold BF, Hinterwirth A, Lebas E, O'Brien KS, Lietman TM. Mass azithromycin distribution and antibiotic resistance in the gut and nasopharynx: a cluster-randomized trial. Nat Med. 2026 Mar;32(3):859-868. doi: 10.1038/s41591-026-04217-9. Epub 2026 Mar 17. PubMed 41845058 ↗
  • Arzika AM, Amza A, Maliki R, Aichatou B, Bello IM, Beidi D, Galo N, Harouna N, Karamba AM, Mahamadou S, Abarchi M, Ibrahim A, Brandt C, Lebas E, Peterson B, Liu Z, Oldenburg CE, Doan T, Porco TC, Arnold BF, Lietman TM, O'Brien KS. Spillover of Azithromycin Mass Drug Administration and Child Survival: A Secondary Analysis of a Cluster-Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2519693. doi: 10.1001/jamanetworkopen.2025.19693. PubMed 40638118 ↗
  • Peterson B, Arzika A, Maliki R, Abdou A, Aichatou B, Bello IM, Beidi D, Galo N, Harouna N, Karamba AM, Mahamadou S, Abarchi M, Ibrahim A, Lebas E, Liu Z, Brandt C, Colby E, Oldenburg CE, Porco TC, Arnold B, Lietman TM, O'Brien KS. Mass distribution of azithromycin and child mortality among underweight infants in rural Niger: a subgroup analysis of the AVENIR cluster-randomised trial. BMJ Open. 2025 Mar 27;15(3):e097916. doi: 10.1136/bmjopen-2024-097916. PubMed 40147984 ↗
  • O'Brien KS, Arzika AM, Amza A, Maliki R, Aichatou B, Bello IM, Beidi D, Galo N, Harouna N, Karamba AM, Mahamadou S, Abarchi M, Ibrahim A, Lebas E, Peterson B, Liu Z, Le V, Colby E, Doan T, Keenan JD, Oldenburg CE, Porco TC, Arnold BF, Lietman TM; AVENIR study group. Azithromycin to Reduce Mortality - An Adaptive Cluster-Randomized Trial. N Engl J Med. 2024 Aug 22;391(8):699-709. doi: 10.1056/NEJMoa2312093. PubMed 39167806 ↗
  • O'Brien KS, Arzika AM, Amza A, Maliki R, Ousmane S, Kadri B, Nassirou B, Mankara AK, Harouna AN, Colby E, Lebas E, Liu Z, Le V, Nguyen W, Keenan JD, Oldenburg CE, Porco TC, Doan T, Arnold BF, Lietman TM; AVENIR Study Group. Age-based targeting of biannual azithromycin distribution for child survival in Niger: an adaptive cluster-randomized trial protocol (AVENIR). BMC Public Health. 2021 Apr 29;21(1):822. doi: 10.1186/s12889-021-10824-7. PubMed 33926403 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — De-identified data underlying outcomes publications will be made publicly available.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Individual participant data will be made available after publication of the outcomes and will be made available indefinitely.

Access criteria: Once made available, the data will be open access.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2020 to primary completion in Jul 2024, 44 months.

Results were first posted in May 2025, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2019
First posted
Jan 13, 2020
StartActual
Nov 24, 2020
Primary completionActual
Jul 31, 2024
CompletionActual
Jul 31, 2024
Results first posted
May 14, 2025
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04224987
Lead sponsor
University of California, San Francisco
Collaborators
Bill and Melinda Gates Foundation, Ministry of Health, Niger
Responsible party
Sponsor
First posted
Jan 13, 2020
Start date
Nov 24, 2020
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Results posted
May 14, 2025
Last update
Aug 6, 2026

Study contacts

Tom M Lietman, MD
principal investigator · University of California, San Francisco
Kieran S O'Brien, PhD, MPH
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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