Trial · NCT03840148
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 52
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Success at Test of Cure (TOC) in the Microbiological Intent-to-treat (microITT) Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Microbiologic Success at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. |
| Secondary | Clinical Success at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | Symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Composite Success at Test of Cure (TOC) in the Extended Microbiological Intent-to-treat (emicroITT) Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Symptomatic clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Composite Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Microbiological Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. |
| Secondary | Clinical Success at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Composite Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Microbiological Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. |
| Secondary | Clinical Success at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Investigator Opinion of Clinical Success at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | The proportion of patients with clinical success based on investigator opinion at TOC. |
| Secondary | Composite Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. |
| Secondary | Clinical Success in Patients With Cefepime-Resistant Pathogens at End of Treatment (EOT) in the microITT Population | Assessed within 24 hours after last IV dose (up to 15 days from start of treatment) | Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Composite Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. |
| Secondary | Clinical Success in Patients With Cefepime-Resistant Pathogens at Test of Cure (TOC) in the microITT Population | Assessed at Test of Cure visit (occurred once per participant between Study Days 19 to 23) | Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Composite Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
| Secondary | Microbiologic Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | Microbiologic success is eradication defined as demonstration that any gram-negative bacterial pathogen found at study entry (≥10\^5 CFU/mL) is eradicated to \<10\^3 CFU/mL. |
| Secondary | Clinical Success in Patients With Cefepime-Resistant Pathogens at Late Follow Up (LFU) in the microITT Population | Assessed at Late Follow Up visit (occurred once per participant between Study Days 28 to 35) | Clinical success is defined as symptomatic resolution or return to pre-morbid baseline of all UTI-core symptoms and patient is alive, and patient has not received additional antibacterial therapy for cUTI. |
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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