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Comparison · NCT01597973-1a4feff1

Colistin and Placebo vs Colistin and a Carbapenem: Number of Participants Who Develop Colistin Resistance

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. Colistin and Placebo vs Colistin and a Carbapenem: Number of Participants Who Develop Colistin Resistance. Trial comparisons, record NCT01597973-1a4feff1. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01597973-1a4feff1

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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 10.1040.06680.158wilson
Risk in group 20.08670.05320.138wilson
Risk difference, group 1 minus group 20.0173-0.04610.0812newcombe hybrid score
Risk ratio, group 1 over group 21.20.6252.3log
Odds ratio, group 1 over group 21.220.5952.51log
Number needed to treat, for one more participant with the outcome on Colistin and Placebo than on Colistin and a Carbapenem57.7from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Colistin and Placebocolistin and placebo: colistin- loading dose standard, maintenance dose based on patient's renal function placebo- mimic meropenem (blinded)18173OG000
Group 2Colistin and a Carbapenemcolistin and a carbapenem: colistin standard loading dose, maintenance dose based on patient's renal function carbapenem- dose based on patient's renal function15173OG001

Outcome

Type
SECONDARY
Title
Number of Participants Who Develop Colistin Resistance
Description
Determine what treatment regimen (colistin monotherapy (combined with placebo)) or colistin combined a carbapenem (imipenem or meropenem) is more likely to reduce the frequency of emergence of colistin resistance among XDR-GNB isolates during therapy. Measurements of Minimum Inhibitory Concentration of colistin to XDR-GNB. This is shown below as numbers of those subjects who develop colistin resistance and their percentages of the total completed population.
Time frame
patients' resistance data will be collected up to 30 days
Population
Follow up cultures were unable to be obtained for some subjects. Therefore emergence of resistance status for those subjects could not be determined.

Source ClinicalTrials.gov

Trial

Title
Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli (OVERCOME)
NCT number
NCT01597973
Phases
PHASE3
Conditions
Pneumonia, Blood Stream Infection
Interventions
colistin and meropenem, colistin and placebo
Lead sponsor
University of Michigan
Results first posted
2021-11-30

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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