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| Name | Class |
|---|---|
| Centre de Recherche en Sante de Nouna, Burkina Faso | OTHER_GOV |
| Bill and Melinda Gates Foundation | OTHER |
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An estimated 7.7 million pre-school aged children die each year, the majority from infectious diseases. Mass azithromycin distributions for trachoma may have the unintended benefit of reducing childhood mortality. We recently demonstrated the biannual mass azithromycin distribution significantly reduces all-cause child mortality in a cluster randomized trial (MORDOR I) conducted in three diverse regions of Sub-Saharan Africa.
Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and mortality. We propose a cluster randomized trial designed to repeat the original study to confirm the original results in a different geographic study with similarly high child mortality, and to better understand the mechanism behind any effect of azithromycin on child mortality. We hypothesize that biannual mass azithromycin distribution will reduce child mortality compared to placebo, and that this effect will be primarily driven by a reduction in infectious burden.
Objectives:
The study will be conducted in the Nouna District in northwestern Burkina Faso.
Although child health and mortality are improving worldwide, children in the Sahel and sub-Sahel regions of West Africa have the greatest risks of mortality.Burkina Faso's current under-5 mortality rate is estimated 110 per 1,000 live births. Similar to other countries in the region, the major causes of child mortality in Burkina Faso are malaria, respiratory tract infection, and diarrhea. Malnutrition acts as a major underlying contributor to mortality. Interventions that address these underlying causes may be particularly efficacious for reducing mortality.
Younger children at are at a higher risk of mortality. Approximately 2/3rd of under-5 deaths occur during the first year of life. In general, the child mortality rate decreases as age increases. While some improvement has been observed, neonatal mortality is declining at a slower rate than post-neonatal childhood mortality. Many child health interventions are designed specifically for children over 6 months of age, such as vitamin A supplementation, seasonal malaria chemoprevention, and lipid-based nutritional supplementation. Identification of strategies that are safe and effective for the youngest children will be required to address persistently high rates of neonatal and infant mortality.
The MORDOR I study demonstrated a significant reduction in all-cause child mortality following biannual mass azithromycin distribution. Across three diverse geographic locations in sub-Saharan Africa (Malawi, Niger, and Tanzania), biannual mass azithromycin distribution over a two-year period led to a 14% decrease in all-cause child mortality. In Niger, 1 in 5-6 deaths were averted. These results are qualitatively similar to those of a previous study of mass azithromycin distribution for trachoma control in Ethiopia, which found reduced odds of all-cause mortality in children in communities receiving mass azithromycin compared to control communities.
In MORDOR I, the strongest effect of azithromycin was in the youngest cohort of children. Across all three countries, the strongest effect of azithromycin was consistently in children 1-5 months of age, with an approximately 25% reduction in all-cause mortality. However, MORDOR I was not optimized to target the youngest age groups. Although children as young as 1 month were eligible, biannual distributions might not reach some children until 7 months of age. On average, children were first treated at 4 months. Given that there may be a substantial benefit to treating children at younger ages, azithromycin strategies that are designed to target younger age groups may be even more beneficial for reducing child mortality.
Here, we propose a randomized controlled trial designed to evaluate the efficacy of mass and targeted azithromycin strategies for child mortality. In the rural northwestern district of Nouna in Burkina Faso, we propose to randomize villages to biannual mass azithromycin distribution or placebo. This study was designed by CRSN and UCSF partners to confirm the results of MORDOR I, evaluate an alternative health systems distribution point (the vaccine visit) for delivery of azithromycin to young children, and to provide a platform for evaluation of potential mechanisms behind the effect of azithromycin by collecting and processing additional specimens and tests.
Objectives:
Study Design:
CRSN and UCSF (hereafter, "we") will assess childhood mortality over three years, comparing communities where children aged 1-59 months receive biannual oral azithromycin and/or targeted azithromycin during the 5th-12th week of life in conjunction with the first Expanded Programme on Immunization (EPI) vaccine visit or biannual placebo and targeted placebo. All eligible communities in Nouna District will be randomized (278 communities). A random sample of 48 (12/arm) communities from within the HDSS will be selected to participate in the "Mortality Plus" study, which will entail an annual morbidity exam among 15 randomly selected children per community to monitor infectious disease morbidity, nutritional status, and macrolide resistance. All communities will contribute to the mortality outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biannual mass oral azithromycin | Active Comparator | Bi-annual Mass Azithromycin distribution to all children 1-60 months old in participating communities |
|
| Biannual mass oral placebo | Placebo Comparator | Bi-annual Mass Placebo distribution to all children 1-60 months old in participating communities |
|
| Targeted oral placebo | Placebo Comparator | Targeted placebo to children 5 to 12 weeks old at vaccine visit or other healthy child visit |
|
| Targeted oral azithromycin | Active Comparator | Targeted azithromycin to children 5 to 12 weeks old at vaccine visit or other healthy child visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality Rate in Children Aged 1-59 Months | All-cause mortality as determined by biannual census among children aged 1-59 months | 36 months |
| All-cause Mortality Rate in Individually Randomized Children at 4-12 Weeks of Age | All-cause mortality as determined by a follow-up visit for individually randomized children at healthy child visits | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Malaria Parasitemia in Children 1-59 Months at 36 Months | Malaria parasitemia as measured by thin and thick smears in a random sample of children at 36 months | 36 months |
| Weight-for-height Z-score in Individually Randomized Children at Healthy Child Visits |
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Communities:
Inclusion Criteria:
Exclusion criteria:
- Refusal of village chief
Individuals:
Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine E Oldenburg, PhD | University of California, San Francisco | Principal Investigator |
| Tom M Lietman, MD | University of California, San Francisco | Principal Investigator |
| Ali Sie, MD, PhD | Centre de Recherche en Sante de Nouna, Burkina Faso | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherche en Sante de Nouna | Nouna | Burkina Faso |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41662252 | Derived | Gebreegziabher EA, Sie A, Ouattara M, Bountogo M, Coulibaly B, Boudo V, Ouedraogo T, Lebas E, Hu H, Ante-Testard PA, Gregorich SE, O'Brien KS, Hsiang MS, Glidden DV, Arnold BF, Lietman TM, Oldenburg CE. Exploring heterogeneity in treatment effects: The impact and interaction of asset-based wealth and mass azithromycin distribution on child mortality. PLoS One. 2026 Feb 9;21(2):e0341665. doi: 10.1371/journal.pone.0341665. eCollection 2026. | |
| 41626759 |
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De-identified data will be available as per the Bill and Melinda Gates open access policy. Community based data will be available that underline the reported results (texts, tables, figures, and appendices). The study protocol and statistical analysis plan will also be made available. The data will be available following publication in accordance with the BMGF guidelines
december 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | Biannual Mass Oral Azithromycin | Bi-annual Mass Azithromycin distribution to all children 1-60 months old in participating communities Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit |
| FG001 | Biannual Mass Oral Placebo | Bi-annual Mass Placebo distribution to all children 1-60 months old in participating communities Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit Placebos: biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit |
| FG002 | Targeted Oral Azithromycin | Targeted azithromycin to children 5 to 12 weeks old at vaccine visit or other healthy child visit Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit |
| FG003 | Targeted Oral Placebo | Targeted placebo to children 5 to 12 weeks old at vaccine visit or other healthy child visit Placebos: biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The units are all participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Biannual Mass Oral Azithromycin | Bi-annual Mass Azithromycin distribution to all children 1-60 months old in participating communities Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Mortality Rate in Children Aged 1-59 Months | All-cause mortality as determined by biannual census among children aged 1-59 months | Primary analysis included 34399 children in azithromycin clusters and 33847 children placebo clusters during 6 census periods. Person-time for the denominator was calculated by summing the person-time for each intercensal period. Children who were alive during both censuses contributed the person-time for that intercensal period. A cluster that was not censused, eg, due to security, could reenter the study at a later census. | Posted | Number | deaths per 1000 person years | 36 months |
|
For the Biannual Mass Oral Azithromycin/Placebo arm, adverse events among infants <6 months of age participating in the first treatment round in a subset of 48 study clusters. Adverse events were collected 2 weeks following the distribution of azithromycin or placebo. For Targeted Oral Azithromycin/Placebo arm, active surveillance for adverse events was performed in a random sample of 10% of enrolled infants and recorded at 2 weeks after administration of azithromycin or placebo.
All-cause mortality was monitored at every census/visit in all arms. The number at risk for mortality reflects children included over the study period.
Adverse events (AEs) were collected for 2 weeks post-distribution: in all selected clusters for Biannual Mass Az/Pl arms and a 10% random sample in the Targeted Az/Pl arm. The number at risk for AEs refers to children completing the 2-week follow-up, which differs from the Participant Flow module.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biannual Mass Oral Azithromycin | Bi-annual Mass Azithromycin distribution to all children 1-60 months old in participating communities Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Lietman, Director of the UCSF FI Proctor Foundation | University of California, San Francisco FI Proctor Foundation | 415-476-1442 | tom.lietman@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 18, 2022 | Jan 7, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2023 | Dec 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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All eligible communities in Nouna District will be randomized in a 1:1 fashion to biannual azithromycin or placebo. Targeted treatment (vaccine visit) will be randomized 1:1 individually to azithromycin or placebo. Randomization will be conducted by T. Porco. Procedural and algorithmic details are provided in an appendix to the Statistical Analysis Plan.
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The trial sites will be masked to outcomes, so the responsibility for monitoring interim analysis will fall on the DSMC
| Placebos | Drug | biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit |
|
The WHZ is calculated using weight (kg) and height (cm) measurements taken at healthy child visits and converted into Z-scores using the WHO Growth Standards. Z-scores represent the number of standard deviations from the median of a reference population. A WHZ of 0 represents the median of the reference population, while negative Z-scores indicate below-average weight-for-height, and positive Z-scores indicate above-average weight-for-height. A WHZ below -2 is indicative of wasting, while a WHZ above +2 is considered overweight. |
| 6 months |
| Height-for-age Z-score in Individually Randomized Children at Healthy Child Visits | The Height-for-age Z-score (HAZ) is calculated using height (cm) measurements taken at healthy child visits and converted into Z-scores using the WHO Growth Standards. Z-scores represent the number of standard deviations from the median of a reference population. A HAZ of 0 represents the median of the reference population, while negative Z-scores indicate below-average height-for-age, and positive Z-scores indicate above-average height-for-age. A HAZ below -2 is indicative of stunting, reflecting chronic undernutrition or growth failure. | 6 months |
| Mid-upper Arm Circumference in Individually Randomized Children at Healthy Child Visits | 6 months |
| Linear Growth in Individually Randomized Children | Change in length per day from baseline to 6 months | 6 months |
| Weight Gain in Individually Randomized Children | Change in weight per day from baseline to 6 months | 6 months |
| Derived |
| Oldenburg CE, Coulibaly B, Sie A, Ouattara M, Bountogo M, Compaore G, Kiemde D, Compaore A, Zonou G, Hinterwirth A, Zhong L, Chen C, Liu Y, Yu D, Abraham T, Lebas E, Hu H, Hilde-Jones M, Arnold BF, Doan T, Lietman TM. Macrolide and non-macrolide resistance after 36 months of mass azithromycin distribution in Burkina Faso: A cluster randomized trial. Clin Infect Dis. 2026 Jan 31:ciag051. doi: 10.1093/cid/ciag051. Online ahead of print. |
| 40779591 | Derived | Bountogo M, Ouattara M, Dah C, Coulibaly B, Ouedraogo T, Zakane A, Boudo V, Lebas E, Hu H, Arnold BF, Lietman TM, Sie A, Oldenburg CE. Azithromycin for infants at risk of poor growth and development: A pooled secondary analysis of two randomized controlled trials. PLoS One. 2025 Aug 8;20(8):e0328208. doi: 10.1371/journal.pone.0328208. eCollection 2025. |
| 40630579 | Derived | Gebreegziabher EA, Sie A, Ouattara M, Bountogo M, Coulibaly B, Boudo V, Ouedraogo T, Lebas E, Hu H, Ante-Testard PA, Gregorich SE, O'Brien KS, Hsiang MS, Glidden DV, Arnold BF, Lietman TM, Oldenburg CE. Exploring Heterogeneity in Treatment Effects: The Impact and Interaction of Asset-Based Wealth and Mass Azithromycin Distribution on Child Mortality. medRxiv [Preprint]. 2025 Jul 6:2025.07.05.25329685. doi: 10.1101/2025.07.05.25329685. |
| 40343013 | Derived | Gebreegziabher EA, Ouattara M, Bountogo M, Coulibaly B, Boudo V, Ouedraogo T, Lebas E, Hu H, O'Brien KS, Hsiang MS, Glidden DV, Arnold BF, Lietman TM, Sie A, Oldenburg CE. The role of Seasonal Malaria Chemoprevention in the effect of Azithromycin on Child Mortality: A Secondary Analysis of the CHAT Cluster Randomized Clinical Trial. medRxiv [Preprint]. 2025 May 2:2025.04.30.25326740. doi: 10.1101/2025.04.30.25326740. |
| 39466816 | Derived | Sie A, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Dah C, Compaore G, Lebas E, Hu H, Porco TC, Arnold BF, O'Brien KS, Lietman TM, Oldenburg CE. Mass azithromycin for prevention of child mortality among children with acute malnutrition: A subgroup analysis of a cluster randomized controlled trial. PLOS Glob Public Health. 2024 Oct 28;4(10):e0003875. doi: 10.1371/journal.pgph.0003875. eCollection 2024. |
| 38349371 | Derived | Oldenburg CE, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaore G, Dah C, Zakane A, Coulibaly B, Bagagnan C, Hu H, O'Brien KS, Nyatigo F, Keenan JD, Doan T, Porco TC, Arnold BF, Lebas E, Sie A, Lietman TM. Mass Azithromycin Distribution to Prevent Child Mortality in Burkina Faso: The CHAT Randomized Clinical Trial. JAMA. 2024 Feb 13;331(6):482-490. doi: 10.1001/jama.2023.27393. |
| 38261579 | Derived | Sie A, Ouattara M, Bountogo M, Dah C, Ouedraogo T, Boudo V, Lebas E, Hu H, Arnold BF, O'Brien KS, Lietman TM, Oldenburg CE. Single-dose azithromycin for infant growth in Burkina Faso: Prespecified secondary anthropometric outcomes from a randomized controlled trial. PLoS Med. 2024 Jan 23;21(1):e1004345. doi: 10.1371/journal.pmed.1004345. eCollection 2024 Jan. |
| 38231623 | Derived | Sie A, Ouattara M, Bountogo M, Boudo V, Ouedraogo T, Compaore G, Dah C, Bagagnan C, Lebas E, Hu H, Rice J, Porco TC, Arnold BF, Lietman TM, Oldenburg CE. Azithromycin during Routine Well-Infant Visits to Prevent Death. N Engl J Med. 2024 Jan 18;390(3):221-229. doi: 10.1056/NEJMoa2309495. |
| 31801563 | Derived | Sie A, Ouattara M, Bountogo M, Bagagnan C, Coulibaly B, Boudo V, Lebas E, Brogdon JM, Lin Y, Barnighausen T, Porco TC, Doan T, Lietman TM, Oldenburg CE; Etude CHAT Study Group. A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol. Trials. 2019 Dec 4;20(1):675. doi: 10.1186/s13063-019-3855-9. |
| Biannual Mass Oral Placebo |
Bi-annual Mass Placebo distribution to all children 1-60 months old in participating communities Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit Placebos: biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit |
| BG002 | Targeted Oral Azithromycin | Targeted azithromycin to children 5 to 12 weeks old at vaccine visit or other healthy child visit Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit |
| BG003 | Targeted Oral Placebo | Targeted placebo to children 5 to 12 weeks old at vaccine visit or other healthy child visit Placebos: biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit |
| BG004 | Total | Total of all reporting groups |
| month |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Biannual Mass Oral Placebo | Bi-annual Mass Placebo distribution to all children 1-60 months old in participating communities Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit Placebos: biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit |
|
|
| Primary | All-cause Mortality Rate in Individually Randomized Children at 4-12 Weeks of Age | All-cause mortality as determined by a follow-up visit for individually randomized children at healthy child visits | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Malaria Parasitemia in Children 1-59 Months at 36 Months | Malaria parasitemia as measured by thin and thick smears in a random sample of children at 36 months | Posted | Count of Participants | Participants | 36 months |
|
|
|
| Secondary | Weight-for-height Z-score in Individually Randomized Children at Healthy Child Visits | The WHZ is calculated using weight (kg) and height (cm) measurements taken at healthy child visits and converted into Z-scores using the WHO Growth Standards. Z-scores represent the number of standard deviations from the median of a reference population. A WHZ of 0 represents the median of the reference population, while negative Z-scores indicate below-average weight-for-height, and positive Z-scores indicate above-average weight-for-height. A WHZ below -2 is indicative of wasting, while a WHZ above +2 is considered overweight. | 13641 children in Targeted oral azithromycin arm and 13657 children in Targeted oral placebo arm had valid height and weight measurement | Posted | Mean | Standard Deviation | z-score | 6 months |
|
|
|
| Secondary | Height-for-age Z-score in Individually Randomized Children at Healthy Child Visits | The Height-for-age Z-score (HAZ) is calculated using height (cm) measurements taken at healthy child visits and converted into Z-scores using the WHO Growth Standards. Z-scores represent the number of standard deviations from the median of a reference population. A HAZ of 0 represents the median of the reference population, while negative Z-scores indicate below-average height-for-age, and positive Z-scores indicate above-average height-for-age. A HAZ below -2 is indicative of stunting, reflecting chronic undernutrition or growth failure. | 13641 children in Targeted oral azithromycin arm and 13657 children in Targeted oral placebo arm had valid height and weight measurement | Posted | Mean | Standard Deviation | z score | 6 months |
|
|
|
| Secondary | Mid-upper Arm Circumference in Individually Randomized Children at Healthy Child Visits | 13641 children in azithromycin group and 13657 children in placebo group had valid MUAC measurement at 6 month | Posted | Mean | Standard Deviation | cm | 6 months |
|
|
|
| Secondary | Linear Growth in Individually Randomized Children | Change in length per day from baseline to 6 months | 13641 children in azithromycin group and 13657 children in placebo group had valid length measurement at 6 month | Posted | Mean | Standard Deviation | mm/day | 6 months |
|
|
|
| Secondary | Weight Gain in Individually Randomized Children | Change in weight per day from baseline to 6 months | 13641 children in azithromycin group and 13657 children in placebo group had valid weight measurement at 6 month | Posted | Mean | Standard Deviation | g/day | 6 months |
|
|
|
| 498 |
| 34,399 |
| 0 |
| 269 |
| 77 |
| 269 |
| EG001 | Biannual Mass Oral Placebo | Bi-annual Mass Placebo distribution to all children 1-60 months old in participating communities Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit Placebos: biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit | 588 | 33,847 | 0 | 199 | 14 | 199 |
| EG002 | Targeted Oral Azithromycin | Targeted azithromycin to children 5 to 12 weeks old at vaccine visit or other healthy child visit Azithromycin: biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit | 82 | 16,416 | 5 | 1,606 | 62 | 1,606 |
| EG003 | Targeted Oral Placebo | Targeted placebo to children 5 to 12 weeks old at vaccine visit or other healthy child visit Placebos: biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit | 75 | 16,461 | 1 | 1,532 | 79 | 1,532 |
| Hospitalization | General disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Organic Chemicals |