Trial · NCT03148756
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population | Day 84 | Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event. |
| Secondary | Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Number of Participants With Day 84 Mortality in the Safety Population | Day 84 | Day 84 mortality was measured by the number of deaths up to Day 84. |
| Secondary | Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population | Day 84 | Clinical outcome was either success or failure/relapse. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population | Day 84 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population | Day 42 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population | Day 84 | Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. |
| Secondary | Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population | Day 42 | Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures. |
| Secondary | Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population | Day 84 | Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures. |
| Secondary | Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population | Day 42 | Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures. |
| Secondary | Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population | Day 84 | Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures. |
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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