Trial · NCT01096849
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Attained Microbiological Eradication (MBE) at the Test of Cure (TOC) Visit in the Microbiological Intent to Treat (MITT) Population | Day 1 to TOC (Day 12) | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients Who Attained MBE at the TOC Visit in the Microbiologically Evaluable (ME) Population | Day 1 to TOC (Day 12) | The ME population was defined as clinically evaluable (CE) patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | percentage of patients | NUMBER |
| PRIMARY | Percentage of Patients With Treatment-Emergent Adverse Events (TEAE) | Day 1 to the end of study (Day 40) | The Safety population was defined as all randomized patients who received any amount of study drug. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at TOC Visit in the Intent-to-treat (ITT) Population | Day 1 to TOC (Day 12) | The intent-to-treat (ITT) population was defined as all randomized patients. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the TOC Visit in the CE Population | Day 1 to TOC (Day 12) | The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained Clinical Cure Based on Investigator and Sponsor Assessments at the End of Treatment (EOT) Visit in the CE Population | Day 1 to EOT (Day 5) | The CE population was defined as patients who received at least 80% of study drug for clinical successes or 40% for clinical failures and must not have had indeterminate clinical response at TOC. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the EOT Visit in the ME Population | Day 1 to EOT (Day 5) | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the EOT Visit in the MITT Population | Day 1 to EOT (Day 5) | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Baseline Pathogen | Day 1 to TOC (Day 12) | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population Stratified by Infection Category | Day 1 to TOC (Day 12) | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Attained MBE at the TOC Visit in the ME Population by Country/Region | Day 1 to TOC (Day 12) | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | percentage of patients | NUMBER |
| SECONDARY | Time (Days) to Resolution of Signs and Symptoms of cUTI and AP in the MITT Population | Day 1 to End of Study (Day 40) | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | days | MEAN |
| SECONDARY | Time (Days) to Clinical Cure Based on Investigator's and Sponsor's Assessments in the MITT Population | Day 1 to End of Study (Day 40) | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | days | MEAN |
| SECONDARY | Time (Days) to Defervescense in the MITT Population | Day 1 to End of Study (Day 40) | The MITT population was defined as a subset patients from the ITT population with at least one isolated causative pathogen from an acceptable pretreatment urine specimen. | days | MEAN |
| SECONDARY | Percentage of Patients Experiencing a Clinical Relapse or Microbiological Recurrence in the ME Population | Day 1 to LTFU (Day 40) | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients With a Superinfection or New Infection in the ME Population | Day 1 to to End of Study (Day 40) | The ME population was defined as CE patients who had a causative pathogen isolated at baseline (ie, patients in both the MITT and CE populations). To be included in the ME population, a patient must also have had results obtained from non-contaminated urine culture at TOC. | percentage of patients | NUMBER |
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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