Trial · NCT03425396
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With an Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit (ITT Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The Intent-to-Treat (ITT) Population consisted of all randomized participants regardless of whether or not the participant received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the End of Treatment (EOT) Visit (ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The ITT Population consisted of all randomized participants regardless of whether or not the participant received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (Microbiological [Micro]-ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The micro-ITT population consisted of all randomized participants who had a study-qualifying pre-treatment Baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 colony forming unit (CFU)/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the EOT Visit (CE-EOT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The clinically evaluable (CE)-EOT population consisted of all ITT participants who completed the EOT visit, received test article, had a qualifying infection, an assessment of outcome, and met all other evaluability criterias. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (CE-PTE Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The clinically evaluable (CE)-PTE population consisted of all ITT participants who completed the PTE visit, received test article, had a qualifying infection, an assessment of outcome, and met all other evaluability criterias. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the PTE Visit (Micro-ITT Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The micro-ITT population consisted of consisted of all randomized participants who had a study-qualifying pre-treatment baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 CFU/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the Final Follow-up (FFU) Visit (ITT Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | The ITT Population consisted of all randomized participants regardless of whether or not the participant received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (CE-FFU Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | The clinically evaluable (CE)-FFU Population consisted of all ITT participants who completed the FFU visit, received test article, had a qualifying infection, an assessment of outcome, and met all other evaluability criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With an Investigator Assessment of Clinical Response at the FFU Visit (Micro-ITT Population) | FFU visit (A FFU occurred 30 to 37 days following the first dose of study drug) | The micro-ITT population consisted of all randomized participants who had a study-qualifying pre-treatment baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 CFU/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Microbiological Response at the EOT Visit (Micro-ITT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The micro-ITT population consisted of all randomized participants who had a study-qualifying pre-treatment baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 CFU/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Microbiological Response at the EOT Visit (ME-EOT Population) | EOT visit (within 1 to 2 days following the last dose of study drug i.e. up to approximately 9 days) | The microbiologically evaluable (ME)-EOT population consisted of participants in the micro-ITT and CE-EOT populations who had a study-qualifying pre-treatment baseline urine culture with 1 or 2 uropathogens at ≥ 10\^5 CFU/mL. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Microbiological Response at the PTE Visit (Micro-ITT Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The micro-ITT population consisted of all randomized participants who had a study-qualifying pre-treatment baseline urine culture. A study-qualifying pretreatment Baseline culture was defined as a culture from a clean-catch urine sample which grew at least 1 and no more than 2 bacterial isolates at ≥ 10\^5 colony forming unit (CFU)/mL each. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With a Microbiological Response at the PTE Visit (ME-PTE Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The ME-PTE population consisted of participants in the micro-ITT and CE-PTE populations who had a study-qualifying pre-treatment baseline urine culture with 1 or 2 uropathogens at ≥ 10\^5 CFU/mL. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Resolution of All Urinary Tract Infection (UTI) Signs and Clinical Symptoms at PTE Visit (ITT Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit were analyzed for this end point. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With No Worsening and Absence of New UTI Signs and Clinical Symptoms at PTE Visit (ITT Population) | Day 14 (A PTE occurred on Day 14 ± 2 days after the participant's first dose of study drug) | The ITT population consisted of all randomized participants regardless of whether or not the participant received study drug. Participants who completed the PTE visit were analyzed for this end point. | Participants | COUNT_OF_PARTICIPANTS |
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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