Azithromycin vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.00266 | 0.00185 | 0.00382 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00137 | 0.000832 | 0.00226 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00129 | 0.000087 | 0.00257 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.94 | 1.04 | 3.62 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.94 | 1.04 | 3.62 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Azithromycin than on Placebo | 776 | 390 | 11,500 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Azithromycin | a single dose of Azithromycin will be administered to infants between their 8-27th days of life~Azithromycin: a single dose of Azithromycin will be administered to infants between their 8-27th days of life | 29 | 10,898 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | a single dose of placebo will be administered to infants between their 8-27th days of life~Placebo: a single dose of Placebo will be administered to infants between their 8-27th days of life | 15 | 10,934 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | 12 months | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso | ClinicalTrials.gov |
| NCT number | NCT03682653 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Childhood Mortality | ClinicalTrials.gov |
| Interventions | Azithromycin, Placebo | ClinicalTrials.gov |
| Lead sponsor | University of California, San Francisco | ClinicalTrials.gov |
| Results first posted | 2023-06-27 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03682653?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.