Trial · NCT02414399
Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
NCT02414399, Phase 4, Unknown, University of Washington; results first posted 2023-12-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children. Trials, record NCT02414399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02414399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
- NCT number
- NCT02414399
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 1,400 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Pneumonia, Diarrhea, Malaria, Co-infection, Death, Malnutrition
- Interventions
- Azithromycin, Placebo
- First posted
- 2015-04-10
- Last updated
- 2023-12-04
- Results first posted
- 2023-12-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Re-hospitalization or Death | 6 months | Incidence rate of a composite outcome of mortality and hospital readmission during the 6 month post-discharge (follow-up) period. |
| Secondary | Mean Change in Length for Age Z-score (LAZ) Between Baseline and Outcome Assessment | 6 months | Mean change in length for age z-score (LAZ) between baseline and M3 or M6 |
| Secondary | The Number of Children With Diarrhea Re-hospitalizations Following Randomization | 6 months | The number of children with diarrhea re-hospitalizations following randomization through follow-up |
| Secondary | The Number of Children With Acute Respiratory Illness Re-hospitalizations Following Randomization | 6 months | |
| Secondary | The Number of Children With Malnutrition Re-hospitalizations Following Randomization | 6 months | |
| Secondary | The Number of Children With Malaria Re-hospitalizations Following Randomization | 6 months | |
| Secondary | Prevalence of Enteric Pathogen Carriage | 3 months | Prevalence of enteric bacteria, viruses, and protozoa identified by qPCR at 3 months of follow-up |
| Secondary | Prevalence of Streptococcus Pneumoniae Carriage | 6 months | Prevalence of Streptococcus pneumoniae from nasopharyngeal swabs collected at M3 and M6 follow-up timepoints. |
| Secondary | Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin | 6 months (E.coli isolated at baseline, month 3, and month 6) | Among participants with E.coli isolated, # of participants with aizhtromycin resistance detected in E.coli form disc diffusion. |
| Secondary | Proportion of Beta-lactam or Macrolide Resistance in Strep Pneumo in Children and Caregivers | 6 months |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Re-hospitalization or Death | 6 months | cases per 100 child years | NUMBER | |
| SECONDARY | Mean Change in Length for Age Z-score (LAZ) Between Baseline and Outcome Assessment | 6 months | |||
| SECONDARY | The Number of Children With Diarrhea Re-hospitalizations Following Randomization | 6 months | |||
| SECONDARY | The Number of Children With Acute Respiratory Illness Re-hospitalizations Following Randomization | 6 months | |||
| SECONDARY | The Number of Children With Malnutrition Re-hospitalizations Following Randomization | 6 months | |||
| SECONDARY | The Number of Children With Malaria Re-hospitalizations Following Randomization | 6 months | |||
| SECONDARY | Prevalence of Enteric Pathogen Carriage | 3 months | |||
| SECONDARY | Prevalence of Streptococcus Pneumoniae Carriage | 6 months | |||
| SECONDARY | Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin | 6 months (E.coli isolated at baseline, month 3, and month 6) | Children with E.coi isolated randomized to be in the antimicrobial resistance substudy | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Beta-lactam or Macrolide Resistance in Strep Pneumo in Children and Caregivers | 6 months |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Re-hospitalization or Death | Azithromycin (n=702) | Death or rehospitalization | 20.4 | cases per 100 child years | |
| Re-hospitalization or Death | Placebo (n=696) | Death or rehospitalization | 22.5 | cases per 100 child years | |
| Re-hospitalization or Death | Azithromycin (n=702) | Death | 4.7 | cases per 100 child years | |
| Re-hospitalization or Death | Placebo (n=696) | Death | 6.0 | cases per 100 child years | |
| Re-hospitalization or Death | Azithromycin (n=702) | Rehospitalization | 18.8 | cases per 100 child years | |
| Re-hospitalization or Death | Placebo (n=696) | Rehospitalization | 18.6 | cases per 100 child years | |
| Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin | Azithromycin | M0 | 84 | Participants | |
| Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin | Placebo | M0 | 69 | Participants | |
| Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin | Azithromycin | M3 | 52 | Participants | |
| Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin | Placebo | M3 | 30 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Azithromycin (n=702) | 702 | |
| Overall Study | STARTED | Placebo (n=696) | 696 | |
| Overall Study | COMPLETED | Azithromycin (n=702) | 702 | |
| Overall Study | COMPLETED | Placebo (n=696) | 696 | |
| Overall Study | NOT COMPLETED | Azithromycin (n=702) | 0 | |
| Overall Study | NOT COMPLETED | Placebo (n=696) | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Grade 3 (not reported by system) | General disorders | Azithromycin (n=702) | 0 | 702 | |
| other | Grade 3 (not reported by system) | General disorders | Placebo (n=696) | 0 | 696 | |
| other | Grade 2 (not reported by system) | General disorders | Azithromycin (n=702) | 193 | 702 | |
| other | Grade 2 (not reported by system) | General disorders | Placebo (n=696) | 195 | 696 | |
| other | Grade 1 (not reported by system) | General disorders | Azithromycin (n=702) | 81 | 702 | |
| other | Grade 1 (not reported by system) | General disorders | Placebo (n=696) | 81 | 696 | |
| serious | Grade 4 or 5 (cardiac disorders) | Cardiac disorders | Azithromycin (n=702) | 1 | 702 | |
| serious | Grade 4 or 5 (cardiac disorders) | Cardiac disorders | Placebo (n=696) | 1 | 696 | |
| serious | Grade 4 or 5 congenital disorders | Congenital, familial and genetic disorders | Azithromycin (n=702) | 0 | 702 | |
| serious | Grade 4 or 5 congenital disorders | Congenital, familial and genetic disorders | Placebo (n=696) | 1 | 696 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Azithromycin (n=702) | 15 | 702 |
| Total, all-cause mortality | Placebo (n=696) | 19 | 696 |
| Total, other adverse events | Azithromycin (n=702) | 274 | 702 |
| Total, other adverse events | Placebo (n=696) | 276 | 696 |
| Total, serious adverse events | Azithromycin (n=702) | 52 | 702 |
| Total, serious adverse events | Placebo (n=696) | 54 | 696 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD079695 | Azithromycin to prevent post-discharge morbidity and mortality in Kenyan children | WALSON, JUDD L. | UNIVERSITY OF WASHINGTON | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2015 to 2019 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Azithromycin (n=702) vs Placebo (n=696): deaths from any cause | Trial comparisons |
| Azithromycin (n=702) vs Placebo (n=696): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02414399
GET https://conductscience.org/api/trials/v1/NCT02414399/events?page=2