Trial · NCT04040621
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Concentration Time Summary for Ceftazidime and Avibactam | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | Pharmacokinetics (PK) analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Area Under the Plasma Concentration-Time Profile From Time 0 to 8 Hours (AUC0-8 Hours) | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Area Under the Curve From Time Zero to Extrapolated Infinite Time of CAZ-AVI (AUCinf) | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Area Under the Concentration-Time Profile From Time 0 to Time to Last Quantifiable Concentration (AUClast) of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Time to Last Quantifiable Plasma Concentration (Tlast) of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Termination Elimination Half-Life (t1/2) of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Clearance (CL) of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Volume of Distribution of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| PRIMARY | Volume of Distribution During Terminal Phase (Vz) of CAZ-AVI | Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose | PK analysis set included all participants who received a complete IV study dose of CAZ-AVI and had at least 1 ceftazidime and/or avibactam plasma measurement available. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| SECONDARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to maximum of 35 days after last dose of study treatment (maximum of 36 days) | Safety set included all participants who had received any amount of IV study dose of CAZ AVI. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| SECONDARY | Number of Participants With Death and Discontinuations Due to Adverse Events (AEs) | Day 1 up to maximum of 35 days after last dose of study treatment (maximum of 36 days) | Safety set included all participants who had received any amount of IV study dose of CAZ AVI. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| SECONDARY | Number of Participants With Clinically Significant Abnormal Laboratory Values | Baseline up to Day 3 | Safety set included all participants who had received any amount of IV study dose of CAZ AVI. Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. | ||
| SECONDARY | Number of Participants With Clinically Significant Physical Examination Abnormalities | Baseline up to Day 3 | Safety set included all participants who had received any amount of IV study dose of CAZ-AVI.Planned analysis was to report data cohort wise. Due to low enrolment providing data per cohort would risk re-identification of participants. Hence, data are not reported. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04040621/outcomes