Trial · NCT01168713
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment |
| Primary | Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit | 5 to 10 days after the last dose of study drug | Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment |
| Secondary | By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT) | 5 days of study drug treatment | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen. |
| Secondary | By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| Secondary | By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT) | 5 days of study drug treatment | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| Secondary | By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit | 5 to 10 days after the last dose of study drug | Successful response is eradication, presumed eradication or combined eradication/presumed eradication of baseline pathogen |
| Secondary | Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
| Secondary | Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
| Secondary | Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
| Secondary | Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT) | 5 days of study drug treatment | Clinical Success is defined as complete or near-complete resolution of the baseline signs and symptoms of community acquired bacterial pneumonia (CABP); no further study drug for treatment of CABP |
| Secondary | Early Clinical Response in the intent to treat (ITT) population at Day 3 | 3 days of study drug treatment | Clinical success is defined as being both clinically stable and showing clinical improvement based on the symptoms of community acquired bacterial pneumonia (CABP) |
| Secondary | Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population | Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit) | Resolution of all baseline signs and symptoms in the clinically evaluable (CE) population |
| Secondary | Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production | 3 days of study drug treatment | Resolution of cough, dyspnea, chest pain due to pneumonia and sputum production |
| Secondary | Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production | 5 days of study drug treatment | resolution of cough, dyspnea, chest pain due to pneumonia and sputum production |
| Secondary | Percentage of patients at Day 3 who are clinically stable | 3 days of study drug treatment | clinical stability defined as: * Temperature \<=37.8°C * Heart rate \<=100 beats/min * Systolic blood pressure ≥90 mm Hg * Ability to maintain oral intake * Normal mental status (oriented to person, place or time) |
| Secondary | Percentage of patients at the end of treatment (EOT) who are clinically stable | 5 days of study drug treatment | Clinically stable defined as: * Temperature ≤37.8°C * Heart rate ≤100 beats/min * Systolic blood pressure ≥90 mm Hg * Ability to maintain oral intake * Normal mental status (oriented to person, place or time) |
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.
For software
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