Trial · NCT03788967
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response (Combined Clinical Cure and Microbiological Eradication) at Test-of-Cure (TOC) in Micro Intent-to-Treat Population | Day 19 (TOC) | Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) in The Safety Population | From the first dose of administration up to Day 25 post-treatment ± 2 days (up to approximately 27 days) | An Adverse Event (AE) was defined as any untoward medical occurrence in a subject or clinical investigation participant administered a pharmaceutical product, which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational/experimental) product, whether or not related to this product. |
| Secondary | Overall Response (Combined Clinical Cure Plus Microbiological Eradication) At Test-Of-Cure (TOC) In The Microbiologically Evaluable (ME) - TOC Population | Day 19 (TOC) | Overall response is participants with combined clinical cure and microbiological eradication. Clinical cure is defined as complete resolution or significant improvement of signs and symptoms of cUTI or acute pyelonephritis (AP) that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Secondary | Clinical Cure at End-of-Treatment (EOT), TOC, and Sustained Clinical Cure at Late Follow-Up (LFU) Days in the Micro-ITT Populations | Days 15 (EOT), Day 19 (TOC) and Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
| Secondary | Clinical Cure at EOT Days the Clinically Evaluable (CE-EOT) Populations | Day 15 (EOT) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Clinical Cure at TOC in the CE-TOC Populations | Day 19 (TOC) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Sustained Clinical Cure at LFU in the CE-LFU Populations | Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as number of participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
| Secondary | Clinical Cure at EOT in the ME-EOT Populations | Day 15 (EOT) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Clinical Cure at TOC Days in the ME-TOC Populations | Day 19 (TOC) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. |
| Secondary | Sustained Clinical Cure at LFU in the ME-LFU Population | Day 25 (LFU) | Clinical cure is defined as number of participants with complete resolution or significant improvement of signs and symptoms of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted. Sustained clinical cure is defined as participants who met criteria for clinical cure at TOC and remained free of signs and symptoms of cUTI or AP at LFU. |
| Secondary | By-Patient Microbiological Eradication at EOT, TOC, and Sustained Microbiological Eradication at LFU Days in the Micro-ITT Population | Days 15 (EOT), 19 (TOC) and 25 (LFU) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication is defined as number of participants with reduction of Baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at Baseline. Sustained Microbiological Eradication is defined as number of participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL. |
| Secondary | By-Pathogen Microbiological Eradication Rate at EOT in the Micro-ITT Population | Days 15 (EOT) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| Secondary | By-Pathogen Microbiological Eradication Rate at TOC in the Micro-ITT Population | Day 19 (TOC) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| Secondary | By-Pathogen Sustained Microbiological Eradication Rate at LFU in the Micro-ITT Population (m-ITT) | Day 25 (LFU) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined as microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed. |
| Secondary | By-Patient Microbiological Eradication at EOT in the ME-EOT Populations | Day 15 (EOT) | Microbiological eradication is defined as reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. |
| Secondary | By-Patient Microbiological Eradication at TOC in the ME-TOC Population | Day 15 (TOC) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| Secondary | By-Patient Sustained Microbiological Eradication at LFU Days in the ME-LFU Populations | Day 25 (LFU) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 colony forming unit/milliliter (CFU/mL) and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL. |
| Secondary | By-pathogen Microbiological Eradication Rate in Participants at EOT in the ME-EOT Populations | Day 15 (EOT) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogens analyzed. |
| Secondary | By-pathogen Microbiological Eradication Rate in Participants at TOC in the ME-TOC Populations | Day 19 (TOC) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of participants analyzed. |
| Secondary | By-pathogen Sustained Microbiological Eradication Rate in Participants at LFU in the ME-LFU Populations | Day 25 (LFU) | Microbiological eradication is defined as number of participants with reduction of baseline urine pathogen(s) to \<10\^3 CFU/mL and negative repeated blood culture if blood culture was positive for uropathogen growth at baseline. Sustained Microbiological Eradication is defined participants with microbiologic eradication at the TOC and no subsequent urine culture after TOC demonstrating recurrence of the original baseline uropathogen at ≥10\^5 CFU/mL.Microbiological eradication rate is the percentage of pathogens being eradicated from the overall number of pathogen analyzed. |
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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