Trial · NCT03230916
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Imipenem (IMI) Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-∞) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI AUC0-∞ | μM*hr | GEOMETRIC_MEAN |
| PRIMARY | IMI Maximum Concentration (Cmax) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose pharmacokinetic (PK) data point available for IMI Cmax | μM | GEOMETRIC_MEAN |
| PRIMARY | IMI Central Volume of Distribution (Vc) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI Vc | Liters | GEOMETRIC_MEAN |
| PRIMARY | IMI Clearance (CL) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI CL | L/hr | GEOMETRIC_MEAN |
| PRIMARY | IMI Percentage of Time Above the Minimum Concentration (%TMIC) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for IMI %TMIC | Percentage of time | GEOMETRIC_MEAN |
| PRIMARY | Relebactam (REL) AUC0-∞ | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL AUC0-∞ | μM*hr | GEOMETRIC_MEAN |
| PRIMARY | REL Maximum Concentration (Cmax) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Cmax | μM | GEOMETRIC_MEAN |
| PRIMARY | REL Clearance (CL) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL CL | L/hr | GEOMETRIC_MEAN |
| PRIMARY | REL Central Volume of Distribution (Vc) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for REL Vc | Liters | GEOMETRIC_MEAN |
| PRIMARY | Cilastatin (CIL) AUC0-∞ | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Due to sparse PK sampling schedule, per participant data could not be calculated. | ||
| PRIMARY | CIL Time to Maximum Concentration (Tmax) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Tmax | Hours | MEDIAN |
| PRIMARY | CIL Concentration at End of Infusion (Ceoi) | 30 min after the start of infusion for Cohort 1; 60 min after the start of infusion for Cohorts 2-5 | All allocated participants who were compliant with the protocol and had at least 1 post-dose PK data point available for CIL Ceoi | μM | GEOMETRIC_MEAN |
| PRIMARY | CIL Terminal Half-Life (t1/2) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Due to sparse PK sampling schedule, per participant data could not be calculated. | ||
| PRIMARY | CIL Clearance (CL) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to 12 hrs after start of DI for Cohort 5 | Due to sparse PK sampling schedule, per participant data could not be calculated. | ||
| PRIMARY | CIL Volume of Distribution (Vss) | 30 minutes (min) before start of drug infusion (DI) and 10 min after the end of DI for all cohorts; 1.5 to 2.5 hours (hrs) and 4.5 to 6 hrs after start of DI for Cohorts 1-4; 2 to 5 hrs and 6 to12 hrs after start of DI for Cohort 5 | Due to sparse PK sampling schedule, per participant data could not be calculated. | ||
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to 17 days | All allocated participants who received infusion (including partial doses) of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Drug Due to an AE | Day 1 | All allocated participants who received infusion (including partial doses) of study drug | Participants | COUNT_OF_PARTICIPANTS |
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
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GET https://conductscience.org/api/trials/v1/NCT03230916/outcomes