Trial · NCT03557840
Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients
NCT03557840, Not applicable, Unknown, Paul M. Tulkens
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients. Trials, record NCT03557840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03557840
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients
- NCT number
- NCT03557840
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Paul M. Tulkens
- Conditions
- Pharmacokinetics, Antibacterial Agents, Infections, Bacterial, Infection, Drug Monitoring, Temocillin
- Interventions
- temocillin
- First posted
- 2018-06-15
- Last updated
- 2022-05-31
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pharmacokinetics of total plasma temocillin | 12 days | Measurement of total plasma temocillin concentrations (measurement by a validated HPLC-MS-MS after suitable extraction; no predefined value set \[exploratory\]) |
| Primary | pharmacokinetics of unbound plasma temocillin | 12 days | Measurement of unbound plasma temocillin concentrations (measurement by a validated HPLC-MS-MS after separation from protein-bound temocillin; no predefined value set \[exploratory\]) |
| Secondary | Pharmacokinetic analysis and population pharmacokinetics: Cmax (total and free) | 36 months | Analysis of the antibiotic pharmacokinetic profiles by means of appropriate software to calculate the actual mean and median values of the total and free plasma Cmax of temocillin (in mg/L) in the study population and to determine their value in a simulated population (Monte Carlo simulations; 1000 simulated patients) |
| Secondary | Pharmacokinetic analysis and population pharmacokinetics: Cmin (total and free) | 36 months | Analysis of the antibiotic pharmacokinetic profiles by means of appropriate software to calculate the actual mean and median values of the total and free plasma Cmin of temocillin (in mg/L) in the study population and to determine their values in a simulated population (Monte Carlo simulations; 1000 simulated patients) |
| Secondary | Pharmacokinetic analysis and population pharmacokinetics: time above a critical concentration value for total and free concentrations | 36 months | Analysis of the antibiotic pharmacokinetic profiles by means of appropriate software to calculate the actual mean and median values of the fraction of the time between two successive drug administrations during which the total and free plasma concentrations of temocillin remain above a critical value (8 mg/L) in the study population, and to determine its value in a simulated population (Monte Carlo simulations; 1000 simulated patients) |
| Secondary | Covariables analysis (biometric values): weight | 36 months | Assessment of the impact of patient's weight \[in kg\] |
| Secondary | Covariables analysis (biometric values): height | 36 months | Assessment of the impact of patient's height \[in cm\] |
| Secondary | Covariables analysis (biometric values): age | 36 months | Assessment of the impact of patient's age \[in years\] |
| Secondary | Covariables analysis (biochemical data): plasma total protein | 36 months | Assessment of the impact of total plasma protein \[in g/L\] \[in g/L\]. |
| Secondary | Covariables analysis (biochemical data): plasma albumin | 36 months | Assessment of the impact of plasma albumin \[in g/L\]. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers21
The papers the trial lists on ClinicalTrials.gov.
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/NCT03557840
GET https://conductscience.org/api/trials/v1/NCT03557840/papers?page=2