Trial · NCT02168946
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects in the Microbiological Carbapenem-resistant Enterobacteriaceae Modified Intent-to-Treat (mCRE-MITT) Population With a Response of Overall Success [Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Subjects] | at Test of Cure (TOC) visit (Day 12-23) | Overall success is defined as clinical cure \& microbiological eradication. Eradication defined by FDA as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 colony forming unit (CFU)/mL urine. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Primary | All-cause Mortality Rate in the mCRE-MITT Population [Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bacteremia Subjects) | Day 28 | The All-cause mortality rate at Day 28 in the mCRE-MITT population (HABP/VABP and Bacteremia) |
| Primary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure [Complicated Intra-abdominal Infection (cIAI) Subjects Only] | at TOC visit (Day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted. |
| Secondary | The All-cause Mortality Rate in the mCRE-MITT Population (All Indications) | at Day 28 | All Cause Mortality at Day 28 in the mCRE-MITT population (all indications) |
| Secondary | The All-cause Mortality Rate in the m-MITT Population (All Indications) | at Day 28 | The All Cause Mortality rate at Day 28 in the m-MITT population (all indications) |
| Secondary | The All-cause Mortality Rate in the mCRE-MITT Population (cUTI/AP) | at Day 28 | All Cause Mortality at Day 28 in the mCRE-MITT population (cUTI/AP subjects only) |
| Secondary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (All Indications) | at End of Therapy (EOT) visit (7-14 days) and TOC visit (12-23 days) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (cUTI/AP Subjects Only) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the mCRE-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the Microbiological Modified Intent-to-Treat (m-MITT) Population With a Clinical Outcome of Cure (All Indications) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs and symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (cUTI/AP) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the m-MITT Population With a Clinical Outcome of Cure (HABP/VABP and Bacteremia) | at EOT visit (7-14) and TOC visit (day 12-23) | Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the mCRE-MITT Population With a Microbiological Outcome of Eradication (All Indications) | at EOT visit (7-14) and TOC visit (day 12-23) | Includes subjects with microbiologic eradication or presumed eradication as defined: microbiologic eradication of the baseline pathogen or absence of culture result (microbiologic outcome of indeterminate or not assesses) where subject is deemed as clinical cure at that visit. For cUTI/AP subjects, demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA). |
| Secondary | Proportion of Subjects in the m-MITT Population With a Microbiological Outcome of Eradication (All Indications) | at EOT visit (7-14) and TOC visit (day 12-23) | Microbiological eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA). |
| Secondary | Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (cUTI/AP) | at EOT visit (7-14) and TOC visit (day 12-23) | Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Eradication defined for cUTI/AP as the demonstration that the bacterial pathogen(s) found at baseline is reduced to \<10x4 CFU/mL urine (FDA). Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
| Secondary | Proportion of Subjects in the m-MITT Populations With a With a Response of Overall Success (Bacteremia Only) | at EOT visit (7-14) and TOC visit (day 12-23) | Proportion of subjects in m-MITT Population with response of cure and microbiological eradication or presumed eradication. Clinical cure defined as complete resolution or significant improvement of the baseline signs \& symptoms, no further antimicrobial warranted. |
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.
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GET https://conductscience.org/api/trials/v1/NCT02168946/registered