Trial Outcomes & Findings for Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia (NCT NCT04040621)
NCT ID: NCT04040621
Last Updated: 2022-09-09
Results Overview
TERMINATED
PHASE1
4 participants
Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dose
2022-09-09
Participant Flow
Hospitalized pediatric participants who were receiving systemic antibiotic therapy for suspected or confirmed nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP) were enrolled.
Only 4 participants were enrolled before trial was stopped prematurely. Data was planned to be reported per cohort but doing so would risk re-identification of participants. Only participant flow and baseline characteristics data are reported for all enrolled participants as 1 reporting group.
Participant milestones
| Measure |
All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI)
Participants received 50 milligram (mg) per kilogram (kg) of CAZ and 12.5 mg/kg of AVI intravenously on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia
Baseline characteristics by cohort
| Measure |
All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI)
n=4 Participants
Participants received 50 mg/kg of CAZ and 12.5 mg/kg of AVI intravenously on Day 1.
|
|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8 hours post dosePopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1: 2, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 13, 24 hours post dosePopulation: 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.
Vz = Dose/(AUCinf × kel).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to maximum of 35 days after last dose of study treatment (maximum of 36 days)Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to maximum of 35 days after last dose of study treatment (maximum of 36 days)Population: 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.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 3Population: 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.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Day 3Population: 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.
Parameters assessed for physical examination included: body weight and height. Abnormality was judged by investigator.
Outcome measures
Outcome data not reported
Adverse Events
All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER