Trial · NCT01371838
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 Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test of Cure (TOC) in CE Population | 7-20 days after last dose of study drug | Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: •Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy •Treatment-limiting AE leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia •Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome |
| Secondary | Clinical Response at End of Treatment (EOT) Visit in MITT Population | Last day of study drug administration | |
| Secondary | Clinical Response at End of Treatment (EOT) Visit in CE Population | Last day of study drug administration | |
| Secondary | Clinical Response at the Test of Cure (TOC) Visit in MITT Population | 7-20 days after last day of study drug administration | |
| Secondary | Clinical Response at the Test of Cure (TOC) Visit in mMITT Population | 7-20 days after last day of study drug administration | |
| Secondary | Clinical Response at the Test of Cure (TOC) Visit in ME Population | 7-20 days after last day of study drug administration | |
| Secondary | Clinical Response at Test of Cure (TOC) Visit by Pathogen in ME Population | 7-20 days after last dose of study drug | |
| Secondary | Per-Pathogen Microbiological Response at Test of Cure (TOC) Visit by Pathogen in ME Population | 7-20 days after last dose of study drug | |
| Secondary | Per-Patient Microbiological Response at Test of Cure (TOC) Visit in mMITT Population | 7-20 days after last day of study drug administration | An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid. |
| Secondary | Per-Patient Microbiological Response at Test of Cure (TOC) Visit in ME Population | 7-20 days after last day of study drug administration | An outcome is considered as favourable if the per-pathogen response for that subject is either Eradication (An adequate source specimen demonstrates absence of the original baseline pathogen) or presumed eradication (An adequate source specimen was not available to culture and the patient was assessed as a clinical cure). Here, an adequate source specimen is defined as any sample that may yield the growth of a CABP pathogen eg, blood, respiratory specimens, or pleural fluid. |
| Secondary | Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in MITT Population | 7-20 days after last day of study drug administration | |
| Secondary | Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC) Visit in CE Population | 7-20 days after last dose of study drug | |
| Secondary | Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in MITT Population | 21-42 days after last day of study drug administration | |
| Secondary | Clinical Relapse at the LFU Visit for Clinical Cure Patients at Test of Cure (TOC) Visit in CE Population | 21-42 days after last day of study drug administration | |
| Secondary | Microbiological Re-infection/Recurrence at LFU Visit in mMITT Population | 21-42 days after last dose of study drug | |
| Secondary | Microbiological Re-infection/Recurrence at LFU Visit in ME Population | 21-42 days after last dose of study drug |
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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