Trial · NCT03309657
Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid
NCT03309657, Phase 1, Phase 2, Completed, Royal Brisbane and Women's Hospital; results first posted 2020-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid. Trials, record NCT03309657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03309657
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics of Ceftolozane/Tazobactam in Plasma and Cerebrospinal Fluid
- NCT number
- NCT03309657
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Royal Brisbane and Women's Hospital
- Conditions
- Pharmacokinetics
- Interventions
- Ceftolozane/tazobactam
- First posted
- 2017-10-13
- Last updated
- 2020-09-10
- Results first posted
- 2020-09-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Unbound Ceftolozane Exposure in the Plasma | Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | Unbound Ceftolozane Exposure in the plasma given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf). |
| Primary | Unbound Tazobactam Exposure in the Plasma | Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | Unbound Tazobactam Exposure in the plasma given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf). |
| Primary | Unbound Ceftolozane Exposure in the CSF | Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | Unbound Ceftolozane Exposure in the CSF given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf). |
| Primary | Unbound Tazobactam Exposure in the CSF | Samples collected from 0 to 8 hours post dose at "0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | Unbound Tazobactam Exposure in the CSF given by the area under the unbound concentration-time curve from time zero to infinity (AUC0-inf). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Unbound Ceftolozane Exposure in the Plasma | Samples collected from 0 to 8 hours post dose at 0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | mg*h/L | MEDIAN | |
| PRIMARY | Unbound Tazobactam Exposure in the Plasma | Samples collected from 0 to 8 hours post dose at 0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | mg*h/L | MEDIAN | |
| PRIMARY | Unbound Ceftolozane Exposure in the CSF | Samples collected from 0 to 8 hours post dose at 0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | mg*h/L | MEDIAN | |
| PRIMARY | Unbound Tazobactam Exposure in the CSF | Samples collected from 0 to 8 hours post dose at 0, 1, 2,4,6, & 8 h post dose were use estimate area under the curve from time zero to infinity estimated by non-compartmental analysis | mg*h/L | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Unbound Ceftolozane Exposure in the Plasma | Ceftolozane Tazobactam | 322.6 | Inter-Quartile Range 182.7 to 413.9 | mg*h/L | |
| Unbound Tazobactam Exposure in the Plasma | Ceftolozane Tazobactam | 52.1 | Inter-Quartile Range 35.7 to 79.6 | mg*h/L | |
| Unbound Ceftolozane Exposure in the CSF | Ceftolozane Tazobactam | 30.2 | Inter-Quartile Range 18.8 to 128.3 | mg*h/L | |
| Unbound Tazobactam Exposure in the CSF | Ceftolozane Tazobactam | 5.6 | Inter-Quartile Range 1.6 to 24.4 | mg*h/L |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftolozane Tazobactam | 10 | |
| Overall Study | COMPLETED | Ceftolozane Tazobactam | 10 | |
| Overall Study | NOT COMPLETED | Ceftolozane Tazobactam | 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 | Ceftolozane Tazobactam | 0 | 10 |
| Total, other adverse events | Ceftolozane Tazobactam | 0 | 10 |
| Total, serious adverse events | Ceftolozane Tazobactam | 0 | 10 |
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/NCT03309657
GET https://conductscience.org/api/trials/v1/NCT03309657/registered