Trial · NCT06059846
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Overall Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (Micro-ITT) Population | At Day 17 (TOC) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data reported is at the TOC timepoint only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response (Combined Per-Participant Clinical Cure and Favorable Microbiological Response) at the TOC Visit in the Microbiologically Evaluable (ME) Population | At Day 17 (TOC) | The ME population includes participants who meet the definition for both the micro-ITT and clinically evaluable (CE) populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). In this outcome measure, data is reported for categories at the TOC timepoint only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response at the End-of-Treatment (EOT) and Late Follow-Up (LFU) Visits in the Micro-ITT Population | At Day 10 (EOT) and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data is reported for categories at EOT and LFU timepoints only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response at EOT and LFU Visits in the ME Population | At Day 10 (EOT) and Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and clinically evaluable (CE) populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. In this outcome measure, data is reported for categories at EOT and LFU timepoints only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the Micro-ITT Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the CE Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The CE population includes participants in the ITT Population or all randomized participants, with no major protocol deviations who received ≥8 doses of study drug (or \<8 if discontinued due to AE or death), had ≥80% treatment compliance, achieved clinical cure or failure at EOT, TOC, or LFU, had a cUTI/AP diagnosis, and did not violate prior antibiotic use criteria. Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at EOT, TOC and LFU Visits in the ME Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the Micro-ITT Population | At Day 10 (EOT), Day 17 (TOC), and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at EOT, TOC and LFU Visits in the ME Population | At Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response at EOT, TOC, and LFU Visits in Participants With Drug-Resistant Enterobacterales in Micro-ITT Population | Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. Here, 'number analyzed' indicates the number of participants analyzed at the specified visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Response at EOT, TOC, and LFU Visits in Participants With Drug-Resistant Enterobacterales in the ME Population | Day 10 (EOT), Day 17 (TOC) and Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME Populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit and Enterobacterales. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the EOT and TOC Visits in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population | Day 10 (EOT) and Day 17 (TOC) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data is reported for categories at EOT and TOC timepoints only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the LFU Visit in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population | At Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data is reported for categories at the LFU timepoint only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the EOT, TOC and LFU Visits in Participants With Drug-resistant Enterobacterales in the ME Population | Day 10 (EOT), Day 17 (TOC) and Day 28(LFU) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the EOT and TOC Visits in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population | Day 10 (EOT) and Day 17 (TOC) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data is reported for categories at EOT and TOC timepoints only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the LFU Visit in Participants With Drug-resistant Enterobacterales in the Micro-ITT Population | At Day 28 (LFU) | The micro-ITT population includes randomized participants with ≥ 10\^5 CFU/mL of an imipenem-susceptible Enterobacterales uropathogen, no other pathogens except an additional Enterobacterales species, E. faecalis, S. aureus, or S. saprophyticus at ≥10\^5 CFU/mL, and no more than two microorganisms in the baseline urine culture. In this outcome measure, data is reported for categories at the LFU timepoint only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the EOT and TOC Visits in Participants With Drug-resistant Enterobacterales in the ME Population | Day 10 (EOT) and Day 17 (TOC) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU). Here, 'number analyzed' indicates the number of participants analyzed at the specified visit and Enterobacterales. In this outcome measure, data is reported for categories at EOT and TOC timepoints only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the LFU Visit in Participants With Drug-resistant Enterobacterales in the ME Population | At Day 28 (LFU) | The ME population includes participants who meet the definition for both the micro-ITT and CE populations. Three ME populations are defined - at EOT (ME-EOT), TOC (ME-TOC), and LFU (ME-LFU) Here, 'number analyzed' indicates the number of participants analyzed at the specified visit and Enterobacterales. In this outcome measure, data is reported for categories at the LFU timepoint only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events | From first dose of study drug (Day 1) up to last follow-up visit (Day 28) | Safety population includes randomized participants who received any amount of the study drug or comparator. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations of TBP-PI-HBr | 0.25 hour (h), 0.5h, 1h, 1.5h, 2h, 4h and 6h postdose at Day 2 | The pharmacokinetics population consists of all participants treated with at least one relevant dose of TBP-PI-HBr with at least one quantifiable plasma sample. The data is reported only for TBP-PI-HBr arm. Population PK analysis was performed with data from the PK population; data reported here was obtained in the subpopulation with intensive PK sampling. | nanograms per milliliter | GEOMETRIC_MEAN |
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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