Trial · NCT05630833
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| 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) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Secondary | Number of Participants With Clinical Outcome at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in total symptom score (CSS) from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met). |
| Secondary | Number of Participants With Clinical Response at the TOC Visit - Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC. |
| Secondary | Number of Participants With Microbiological Outcome (MO) at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC. |
| Secondary | Number of Participants With Microbiological Response at the TOC Visit -Micro-ITT NTF-S Population | At TOC visit (Days 9 to 16) | Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes. |
| Secondary | Number of Participants With Therapeutic Response (TR) at the TOC Visit | At TOC visit (Days 9 to 16) | TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure. |
| Secondary | Number of Participants With Clinical Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Clinical outcome at TOC was categorized as clinical resolution, clinical improvement, clinical worsening and unable to determine. Clinical resolution at TOC was defined as resolution of signs and symptoms of acute cystitis present at BL (and no symptoms) without receiving any other AB before the TOC visit. Clinical improvement at TOC was defined as improvement (but not complete resolution) in CSS from BL, without receiving any other AB before the TOC visit. Clinical worsening at TOC was defined as worsening or no change in CSS from BL or received other AB for the current infection (uUTI) before or on the date of the TOC visit. Unable to determine outcome criteria were: BL score is missing (and thus improvement/worsening cannot be determined), TOC assessment is missing, or receipt of other AB not for the current infection before the TOC visit (unless clinical worsening outcome criteria were met). |
| Secondary | Number of Participants With Clinical Response at the TOC Visit | At TOC visit (Days 9 to 16) | Clinical response at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as resolution of symptoms of acute cystitis present at BL (and no new symptoms), without receiving any other AB before the TOC visit. Lack of resolution, including receipt of an AB for uUTI at the TOC visit, or a missing outcome assessment was defined as Clinical Failure at TOC. |
| Secondary | Number of Participants With Microbiological Outcome at the TOC Visit | At TOC visit (Days 9 to 16) | Participant-level MO at TOC was categorized as microbiological eradication (ME), microbiological persistence (MP), microbiological recurrence (MR) and unable to determine (UTD). ME at TOC was defined as all baseline qualifying uropathogens (QUP) have an outcome of eradication at TOC (i.e., \<10\^3 CFU/mL without the participant receiving other systemic antimicrobials before the TOC Visit). MP at TOC was defined as at least 1 QUP has an outcome of persistence (≥10\^3 CFU/mL) at TOC. MR at TOC was defined as at least 1 QUP had an outcome of recurrence and none have an outcome of persistence at TOC. UTD at TOC was defined as all QUP outcomes are UTD at TOC. |
| Secondary | Number of Participants With Microbiological Response at the TOC Visit | At TOC visit (Days 9 to 16) | Participant-level microbiological response at TOC was categorized as microbiological success and microbiological failure. Microbiological success at TOC was defined as all baseline qualifying uropathogens (QUP) had a microbiological outcome of eradication at TOC visit. Microbiological failure was defined as lack of microbiological success, including those participants with UTD outcomes. |
| Secondary | Number of Participants With Investigator Assessed Clinical Response | At TOC visit (Days 9 to 16) | Clinical response as assessed by investigator at TOC was categorized as clinical success and clinical failure. Clinical success at TOC was defined as sufficient resolution of acute cystitis signs and symptoms such that no additional systemic AB was required for the current infection. No apparent response to treatment, use of additional systemic AB for the current infection and death related to acute cystitis prior to the visit was considered as Clinical failure. Indeterminate/Missing was defined as participant lost to follow-up and/or the clinical assessment was not undertaken, use of confounding systemic AB for another infection, and death prior to the visit where acute cystitis was clearly noncontributory. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose (Day 1) to Follow-up visit (Days 21 to 31) | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. TEAE is defined as any AE with an onset date on or after treatment start date/time. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). |
| 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) | An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Adverse events of special interest (AESI) for gepotidacin included clostridium difficile, cardiovascular \& gastrointestinal events and potential acetylcholinesterase-inhibition AESIs. SAEs were coded using MedDRA. |
| 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) | Urine samples were collected for urinalysis: Urine Glucose (GLU), Urine Ketones (KET), Urine Nitrite (NIT) and Urine Protein (PRO). Baseline is defined as the latest pre-dose assessment with a non-missing value. The dipstick test gives results in a semi-quantitative manner, and results can be read as Negative, Positive, 2777.55 micromole per liter (µmol/l), \>=27775.5 µmol/l, 8332.65 µmol/l, 5 milligram/dl (mg/dL), 20 mg/dL, \>=80 mg/dL, 300 mg/dL, 1000 mg/dL, \>=5000 mg/dL indicating concentrations in the urine sample. In the row title (GLU, Baseline, 2777.55 micromole per liter), GLU indicates parameter, Baseline is the visit and 2777.55 micromole per liter indicates the concentration/presence in the urine sample. Data is presented in similar way for other parameters. |
| 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) | Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QT interval corrected for heart rate according to Fridericia's formula (QTcF). Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| 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) | Triplicate 12-lead ECGs (over an approximate 5 to 10 minute period) were performed using an ECG machine that automatically calculated the heart rate, measured PR, QRS, QT, and QTcF. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| 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) | SBP and DBP were measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| 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) | Temperature was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
| 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) | Pulse rate was measured in a semi-supine position after 5 minutes rest. Baseline is defined as the latest pre-dose assessment with a non-missing value. |
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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