Trial · NCT01808092
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses) | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| Primary | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses) | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| Secondary | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| Secondary | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| Secondary | The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive. |
| Secondary | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| Secondary | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| Secondary | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| Secondary | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| Secondary | The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients meeting the cure criteria: the patient is alive and all signs and symptoms of pneumonia have resolved or improved such that all antibacterial therapies for Nosocomial Pneumonia are stopped. No antibacterial therapy other than those outlined by the protocol has been administered for Nosocomial Pneumonia prior to end of treatment. |
| Secondary | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set | At the test-of-cure (TOC) visit (Day 21 to 25) | Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated". Eradication is defined as: source specimen demonstrates absence of the original baseline pathogen. Presumed eradication is defined as: source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set | Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
| Secondary | The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit | At the test-of-cure (TOC) visit (Day 21 to 25) | The number of patients with a favorable per-pathogen microbiological response: favorable microbiological response includes: Eradication where, source specimen demonstrates absence of the original baseline pathogen. Presumed eradication where, source specimen was not available to culture and the patient was assessed as a clinical cure. |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01808092/registered