Comparison · NCT01594827-b2a48eea
Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture
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: Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture. Trial comparisons, record NCT01594827-b2a48eea. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01594827-b2a48eea
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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 | 0.2 | 0.0567 | 0.51 | wilson | |
| Risk in group 2 | 0.2 | 0.0705 | 0.452 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.29 | 0.336 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.202 | 4.95 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.135 | 7.39 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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. | 2 | 10 | OG000 |
| 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 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Patients MRSA Free by Induced Sputum Respiratory Tract Culture
- Description
The hypothesis for our primary outcome is that the aggressive treatment arm will result in significantly greater eradication of persistent MRSA from the respiratory tract of CF adolescents and adults on day 58 (1 month after completion of therapy) compared to the placebo/standard treatment arm. Our primary outcome will be comparing the proportion of CF patients in the treatment arm who have a negative induced sputum MRSA culture at Day 58 to the proportion of patients in the placebo arm who have a negative induced sputum MRSA culture at Day 58.
- Time frame
- Day 58 (Visit 5), approximately 1 month after completion of the MRSA treatment protocol
- Population
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.
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