Comparison · NCT01349192-sae
Treatment vs Observation: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Treatment vs Observation: serious adverse events. Trial comparisons, record NCT01349192-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01349192-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 | 0.0417 | 0.00739 | 0.202 | wilson | |
| Risk in group 2 | 0.0476 | 0.00846 | 0.227 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00595 | -0.188 | 0.16 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.875 | 0.0583 | 13.1 | log | |
| Odds ratio, group 1 over group 2 | 0.87 | 0.051 | 14.8 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment than on Observation | 168 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment | Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: \<40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: \<40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: \< 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas | 1 | 24 | EG000 |
| Group 2 | Observation | Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist. | 1 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 28 days
Source ClinicalTrials.gov
Trial
- Title
- Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF)
- NCT number
- NCT01349192
- Phases
- PHASE2
- Conditions
- Cystic Fibrosis, Methicillin-resistant Staphylococcus Aureus
- Interventions
- Rifampin, Trimethoprim/Sulfamethoxazole, Minocycline, Mupirocin, chlorhexidine gluconate oral rinse, 2% Chlorhexidine solution wipes, Environmental Decontamination
- Lead sponsor
- University of North Carolina, Chapel Hill
- Results first posted
- 2017-05-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01349192?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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