Comparison · NCT01594827-sae
Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: 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. Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: serious adverse events. Trial comparisons, record NCT01594827-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01594827-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 | 0.0714 | 0.0127 | 0.315 | wilson | |
| Risk in group 2 | 0.2 | 0.0705 | 0.452 | wilson | |
| Risk difference, group 1 minus group 2 | -0.129 | -0.387 | 0.147 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.357 | 0.0419 | 3.04 | log | |
| Odds ratio, group 1 over group 2 | 0.308 | 0.028 | 3.38 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Inhaled Vancomycin and Oral Antibiotics than on Inhaled Placebo (Sterile Water) and Oral Antibiotics | 7.78 | 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 | Inhaled Vancomycin and Oral Antibiotics | In the experimental arm CF participants are randomized to 28 days of inhaled sterile vancomycin (250 mg twice a day) as well as 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. | 1 | 14 | EG000 |
| Group 2 | Inhaled Placebo (Sterile Water) and Oral Antibiotics | In the active comparator arm CF participants are randomized to 28 days of inhaled sterile placebo (saline) and are treated with 28 days of oral/skin antibiotics targeted to aggressively treat MRSA infection: oral rifampin, a second oral antibiotic (TMP/SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes. Patients will be followed for 3 months after completion of the treatment protocol. | 3 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from the time of enrollment until 3 months after completion of treatment.
Source ClinicalTrials.gov
Trial
- Title
- Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP)
- NCT number
- NCT01594827
- Phases
- PHASE2
- Conditions
- Cystic Fibrosis
- Interventions
- Inhaled Vancomycin, Placebo (Sterile Water), Rifampin, Trimethoprim/Sulfamethoxazole (TMP/SMX), Doxycycline, Mupirocin Intranasal Creme, 4% chlorhexidine gluconate liquid skin cleanser
- Lead sponsor
- Johns Hopkins University
- Results first posted
- 2018-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01594827?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.
For software
Read this comparison from software.
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GET https://conductscience.org/api/comparisons/v1/NCT01594827-sae