Trial · NCT01595438
Registered outcomes63
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 63
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient-reported Symptomatic Response at Day 5 (mMITT Analysis Set): Non-inferiority Hypothesis Test | At Day 5 visit. Day 5 visit is based on 24 hour periods from the first dose date and time. | Number of patients with symptomatic resolution (or return to premorbid state) of UTI-specific symptoms except flank pain (frequency/urgency/dysuria/suprapubic pain) with resolution of or improvement in flank pain based on the patient-reported symptom assessment response at the Day 5 visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). |
| Primary | Combined Patient-reported Symptomatic and Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with both a favorable per patient microbiological response and symptomatic resolution (or return to premorbid state) of all UTI-specific symptoms (frequency/urgency/dysuria/suprapubic pain/flank pain) based on the patient-reported symptom assessment response at the TOC visit in the mMITT analysis set. The sponsor will conclude noninferiority if the lower limit of the 95% CI of difference (corresponding to a 97.5% 1-sided lower bound) is greater than -12.5% for both FDA coprimary outcome variables (symptomatic resolution at day 5 or favorable combined response at test of cure (TOC)). |
| Primary | Per-patient Microbiological Response at TOC (mMITT Analysis Set): Non-inferiority Hypothesis Test | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC. The primary efficacy outcome variable for ROW is the proportion of patients with a favorable per-patient microbiological response at the TOC visit in the mMITT analysis set. |
| Secondary | Per-patient Microbiological Response at EOT (IV) (mMITT Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Secondary | Per-patient Microbiological Response at LFU (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Secondary | Per-patient Microbiological Response at EOT (IV) (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Secondary | Per-patient Microbiological Response at TOC (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC |
| Secondary | Per-patient Microbiological Response at LFU (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Secondary | Per-patient Microbiological Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a favorable per-patient microbiological response at EOT (IV) |
| Secondary | Per-patient Microbiological Response at TOC (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a favorable per patient microbiological response at TOC |
| Secondary | Per-patient Microbiological Response at LFU (Extended ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a favorable per patient microbiological response at LFU |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (mMITT Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at TOC (mMITT Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at LFU (mMITT Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at TOC (ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at LFU (ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at EOT (IV) (Extended ME at EOT (IV) Analysis Set) | At EOT (IV) visit. EOT (IV) visit is Within 24 hours after completion of the last infusion of IV study therapy and on/before the first dose for oral study therapy | Number of patients with a clinical cure at EOT (IV). The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at TOC (Extended ME at TOC Analysis Set) | At TOC visit. TOC visit is 21 to 25 days from Randomization. | Number of patients with a clinical cure at TOC. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
| Secondary | Investigator Determined Clinical Response at LFU (Extended ME at LFU Analysis Set) | At LFU visit. LFU visit is 45 to 52 days from Randomization. | Number of patients with a clinical cure at LFU. The investigator should consider the entirety of the patient's clinical course and current status, including an evaluation of signs and symptoms (eg, fever, dysuria, costovertebral angle tenderness) and physical examination in order to classify the patient's clinical response. |
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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