Trial · NCT04040621
Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia
NCT04040621, Phase 1, Terminated, Pfizer; results first posted 2022-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia. Trials, record NCT04040621. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04040621
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia
- NCT number
- NCT04040621
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 4 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia
- Interventions
- Ceftazidime-avibactam
- First posted
- 2019-08-01
- Last updated
- 2022-09-09
- Other registries' IDs
- eudract:2018-002841-12
- Results first posted
- 2022-09-09
- Limitations and caveats
Only 4 participants were enrolled in this study. Outcome measures and AE data were not reported by cohort as planned in the protocol because doing so would risk re-dentification of the individual participants.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI) | 4 | |
| Overall Study | COMPLETED | All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI) | 4 | |
| Overall Study | NOT COMPLETED | All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI) | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI) | 0 | 4 |
| Total, other adverse events | All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI) | 0 | 4 |
| Total, serious adverse events | All Enrolled Participants: Ceftazidime-Avibactam (CAZ-AVI) | 0 | 4 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04040621
GET https://conductscience.org/api/trials/v1/NCT04040621/registered