Trial · NCT04040621
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | |
| 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 | |
| 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 | AUCinf = AUClast + (Clast\*/ kel), where Clast\* is the estimated concentration at the time of the last quantifiable concentration and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. CL = Dose/AUCinf. |
| 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 | Volume of distribution at steady state (Vss) = Clearance (CL) × Mean Residence Time (MRT), MRT = Area under the first moment curve from 0 time to infinity (AUMCinf)/AUCinf - (infusion time/2), AUMCinf = AUMClast + (t × Cest1\*/kel) +(Cest1\*/kel2), 1Cest = e(-KEL × Tlast) × KELC0 , where C0 is the back-extrapolated concentration at time zero. |
| 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 | Vz = Dose/(AUCinf × kel). |
| 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) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| 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) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Secondary | Number of Participants With Clinically Significant Abnormal Laboratory Values | Baseline up to Day 3 | Following parameters were analyzed for laboratory examination: Clinical Chemistry-sodium, potassium, chloride, bicarbonate, creatinine, blood urea nitrogen, glucose-non fasting, calcium, phosphorus, magnesium, alkaline phosphatase, gamma glutamyl transferase, aspartate transaminase, alanine transaminase, creatinine kinase, lactate dehydrogenase, indirect bilirubin, total bilirubin; Hematology- hematocrit, hemoglobin, red blood cells (RBC), white blood cells (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophils immature, platelets, mean cell volume, mean cell hemoglobin, β- human chorionic gonadotropin (hCG) pregnancy test (blood or urine) for females; Urinalysis- appearance (color, clarity), bilirubin, glucose, ketones leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen, microscopic (RBC, WBC, casts, crystals, bacteria, yeast, parasites). |
| Secondary | Number of Participants With Clinically Significant Physical Examination Abnormalities | Baseline up to Day 3 | Parameters assessed for physical examination included: body weight and height. Abnormality was judged by investigator. |
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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