Comparison · NCT05470517-sae
Standard of Care and Antibiotic Instillation (Arm B) vs Standard of Care (Arm A): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Standard of Care and Antibiotic Instillation (Arm B) vs Standard of Care (Arm A): serious adverse events. Trial comparisons, record NCT05470517-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05470517-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.194 | wilson | |
| Risk in group 2 | 0 | 0 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.194 | 0.194 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Standard of Care and Antibiotic Instillation (Arm B) | Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy and subsequent instillation of 10ml of intra-peritoneal ceftriaxone (2g)~Ceftriaxone: Ceftriaxone is a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for intravenous, intramuscular, or intra-peritoneal administration.~Ceftriaxone is a white powder, which is soluble in water. In this study ceftriaxone crystalline powder will be dissolved in 0.9% sodium chloride solution prior to intra-peritoneal instillation.~Antibiotic instillation will be introduced into the RLQ/pelvis after the appendectomy is completed and all intra-peritoneal fluid is aspirated. Ceftriaxone solution will be used depending on availability and pharmacy stock for use at Johns Hopkins All Children's Hospital. The ceftriaxone powder (2g) will be dissolved in 9ml of sterile normal saline, for a total instillation volume of 10ml. This fluid will then be instilled and left to dwell in the area of the peritoneal cavity where the appendix was removed.~Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy. | 0 | 16 | EG001 |
| Group 2 | Standard of Care (Arm A) | Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy.~Intra-peritoneal Fluid Aspiration: Intra-operative aspiration of intra-peritoneal fluid after successful appendectomy. | 0 | 16 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 30 days post operatively
Source ClinicalTrials.gov
Trial
- Title
- Antibiotic Instillation in Appendicitis
- NCT number
- NCT05470517
- Phases
- PHASE2
- Conditions
- Complicated Appendicitis, Acute Appendicitis
- Interventions
- Ceftriaxone, Intra-peritoneal Fluid Aspiration
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Results first posted
- 2025-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05470517?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- 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
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
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.
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