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Trial · NCT03163446

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence of Adverse Events [Safety and Tolerability]Through Day 7, at Test of Cure (TOC) between 56-70 days, and at Day 180Safety populationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYClinical Outcome at Day 14Day 14Microbiological Intent-to-Treat (mITT) populationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYCF-301 Maximum Plasma Concentration (Cmax)Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusionPK Population (patients with serial PK samples)ng/mLMEAN
PRIMARYCF-301 Area Under the Curve (AUC 0-t)Pre-dose and at 0.5, 1.5, 2, 2.25, 3, 4, 8, 14, 24, and 48 hours after the start of CF-301 infusionPK Population (patients with serial PK samples)ng*hr/mLMEAN
SECONDARYClinical Outcome at Day 7Day 7mITT populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClinical Outcome at End of Standard of Care Antibacterial Therapy (EOT)EOT between 28-42 daysmITT populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClinical Outcome at Test of Cure (TOC)TOC between 56-70 daysmITT populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClearance of Bacteremia at Day 7 After CF-301/Placebo AdministrationDay 7mITT populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYClearance of Bacteremia at Day 14 After CF-301/Placebo AdministrationDay 14mITT populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMicrobiological Eradication at End of Standard of Care Antibacterial Therapy (EOT)EOT between 28-42 daysmITT populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMicrobiological Eradication at Test of Cure (TOC)TOC between 56-70 daysmITT populationParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDClinical Outcome at Day 14 in MRSA SubgroupDay 14Microbiological Intent-to-Treat (mITT) populationParticipantsCOUNT_OF_PARTICIPANTS
POST_HOCClinical Responders at Day 14 in Patients With cBSI/R-IEDay 14mITT populationParticipantsCOUNT_OF_PARTICIPANTS
POST_HOCHealth Resource Utilization: Length of Hospital StayFrom study drug dosing to hospital discharge (in patients discharged alive) through Day 180Microbiological Intent-to-Treat (mITT) populationdaysMEDIAN
POST_HOCAll-cause Mortality at Day 30 in MRSA SubgroupDay 30Microbiological Intent-to-Treat (mITT) populationParticipantsCOUNT_OF_PARTICIPANTS

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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