A Phase 4 interventional study of Azithromycin for Oral Suspension in Resistance Bacterial, Morality and Child Health, sponsored by University of California, San Francisco. Terminated at 1 site in United States. Open to participants aged 1 Month and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
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.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Intervention
At the community-level, eligibility includes:
Inclusion Criteria:
Exclusion criteria:
At the individual-level, eligibility includes:
Inclusion criteria:
Exclusion criteria:
Population-based sample collections
At the community-level, eligibility includes:
Inclusion criteria:
Exclusion criteria:
At the individual-level, eligibility includes:
Inclusion criteria:
Exclusion criteria:
Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
Drug: Azithromycin for Oral Suspension
No additional intervention.
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.
Also known as: Zithromax
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
Time frame: 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).
Time frame: 2 years
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.
Time frame: 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).
Time frame: 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
Time frame: 2 years
| Milestone | Programmatic Azithro 1-11 | no Intervention |
|---|---|---|
| Started | 135754 | 33953 |
| Completed | 135754 | 33953 |
| Not completed | 0 | 0 |
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
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
Number of all-cause clinic visits per month for children aged 1-59 months over 1 year
No measurements were reported for this outcome.
Collected over Reporting adverse event data began with the first round of treatment through the last round of treatment. If a child experiences an adverse event within 28 days of treatment, it was reported. time frame for reporting was 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Programmatic Azithro 1-11 | 0/135,754 (0%) | 0/135,754 (0%) | 0/135,754 (0%) |
| No Intervention | 0/33,953 (0%) | 0/33,953 (0%) | 0/33,953 (0%) |
Inclusion criteria includes: age 1-59 months, primary residence in a study community, verbal consent of caregiver/guardian of children for study participation, weight ≥ 3.0 kg. Children were enrolled for participation. not guardians. The No Intervention arm data was not collected given the pragmatic design of the trial; therefore, the Programmatic Azithro 1-11 data was used to estimate the No Intervention population (33,953).
| Age, Categorical(Participants) | Programmatic Azithro 1-11 | No Intervention | Total |
|---|---|---|---|
| <=18 years | 135,754 | 33,953 | 169707 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Programmatic Azithro 1-11 | No Intervention | Total |
|---|---|---|---|
| Female | — | — | 0 |
| Male | — | — | 0 |
| Race and Ethnicity Not Collected(Participants) | Programmatic Azithro 1-11 | No Intervention | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Programmatic Azithro 1-11 | No Intervention | Total |
|---|---|---|---|
| Niger | 135,754 | 33,953 | 169707 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data underlying outcomes publications will be made publicly available.
Supporting information: Study protocol, Sap, Icf
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco