Trial · NCT05630833
Outcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S population. Participants in micro-ITT population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S). Additionally, for the statistical analysis, therapeutic success data from the pooled global studies 204989 (NCT04020341) and 212390 (NCT04187144) were used to derive the predictive distribution, to assess the consistency of gepotidacin's therapeutic success in the current study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Therapeutic Response (TR) of Gepotidacin Compared to Nitrofurantoin at the Test of Cure (TOC) Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population. Participants in the micro-ITT Population whose baseline qualifying bacterial UP were susceptible to nitrofurantoin (NTF-S). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Micro-ITT NTF-S Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Therapeutic Response (TR) at the TOC Visit | At TOC visit (Days 9 to 16) | Microbiological intent-to-treat multi drug resistant (Micro-ITT MDR) population included all participants in the micro-ITT Population who had any qualifying baseline bacterial uropathogens that were resistant to two or more classes of antimicrobials. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Micro-ITT MDR Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Response at the TOC Visit | At TOC visit (Days 9 to 16) | Micro-ITT MDR Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Micro-ITT MDR Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Microbiological Response at the TOC Visit | At TOC visit (Days 9 to 16) | Micro-ITT MDR Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Investigator Assessed Clinical Response | At TOC visit (Days 9 to 16) | ITT population: All participants (except for 6 participants from the site with GCP violation) were randomly assigned to the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose (Day 1) to Follow-up visit (Days 21 to 31) | Safety Population included all randomized participants (except for 6 participants from the site with GCP violation) who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious AEs (SAEs) and Adverse Events of Special Interest (AESIs) | From first dose (Day 1) to Follow-up visit (Days 21 to 31) | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Urinalysis Dipstick Results | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Safety Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline (CFB) in Electrocardiograms (ECGs): Heart Rate | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Safety Population. Only those participants with data available at specified time points have been analyzed. | beats/minute | MEAN |
| SECONDARY | Change From Baseline (CFB) in Electrocardiograms (ECGs): PR, QRS, QT and QTcF | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Safety Population. Only those participants with data available at specified time points have been analyzed. | Millisecond (msec) | MEAN |
| SECONDARY | Change From Baseline (CFB) in Vital Sign: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Safety Population. Only those participants with data available at specified time points have been analyzed. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline (CFB) in Vital Sign: Temperature | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Safety Population. Only those participants with data available at specified time points have been analyzed. | Celsius | MEAN |
| SECONDARY | Change From Baseline (CFB) in Vital Sign: Pulse Rate | Baseline (Day 1), On-Therapy (Days 2 to 5), and at TOC visit (Days 9 to 16) | Safety Population. Only those participants with data available at specified time points have been analyzed. | beats/minute | 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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05630833/outcomes