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Trial · NCT01969799

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .
Amikacin Fosfomycin Inhalation Solution-0.76Standard Error 0.403units on a scale
Change From Baseline in Clinical Pulmonary Infection Score (CPIS) For Each Patient, Value Obtained From a Daily Assessment Over the 10 Day Study Period Was Compared to Baseline, and the LSM Data Represent the Change From Baseline Data Over All Days .
Aerosolized Placebo-0.88Standard Error 0.391units on a scale
Composite Endpoint of Mortality and Clinical CureAmikacin Fosfomycin Inhalation SolutionMortality first10participants
Composite Endpoint of Mortality and Clinical CureAerosolized PlaceboMortality first10participants
Composite Endpoint of Mortality and Clinical CureAmikacin Fosfomycin Inhalation SolutionClinical Cure first15participants
Composite Endpoint of Mortality and Clinical CureAerosolized PlaceboClinical Cure first18participants
Composite Endpoint of Mortality and Ventilator-free DaysAmikacin Fosfomycin Inhalation SolutionMortality first10participants
Composite Endpoint of Mortality and Ventilator-free DaysAerosolized PlaceboMortality first10participants
Composite Endpoint of Mortality and Ventilator-free DaysAmikacin Fosfomycin Inhalation SolutionVentilator free days13participants
Composite Endpoint of Mortality and Ventilator-free DaysAerosolized PlaceboVentilator free days27participants
Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28Amikacin Fosfomycin Inhalation Solution9.8Standard Deviation 9.71Days ± SD
Number of Days Free of Mechanical Ventilation From Day 1 Through Day 28Aerosolized Placebo12.5Standard Deviation 9.72Days ± SD
Number of ICU Days From Day 1 Through Day 28Amikacin Fosfomycin Inhalation Solution28.9Standard Deviation 12.44Days
Number of ICU Days From Day 1 Through Day 28Aerosolized Placebo26.2Standard Deviation 12.44Days
Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative BacteriaAmikacin Fosfomycin Inhalation Solution10Participants
Microbiological Response Rates in Patients Positive for Multi-drug Resistant Gram-negative BacteriaAerosolized Placebo7Participants
Mortality From Day 1 Through Day 28Amikacin Fosfomycin Inhalation Solution17participants
Mortality From Day 1 Through Day 28Aerosolized Placebo12participants
Clinical Relapse RateAmikacin Fosfomycin Inhalation Solution10participants
Clinical Relapse RateAerosolized Placebo14participants

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
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
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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