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Comparison · NCT01594827-deaths

Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: deaths from any cause

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. Inhaled Vancomycin and Oral Antibiotics vs Inhaled Placebo (Sterile Water) and Oral Antibiotics: deaths from any cause. Trial comparisons, record NCT01594827-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01594827-deaths

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 100.00000000000000001390.215wilson
Risk in group 2000.204wilson
Risk difference, group 1 minus group 20-0.2040.215newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Inhaled 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.
014EG000
Group 2Inhaled 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.
015EG001

Harm

What it counts
Total, all-cause mortality
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

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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