|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 January 2021 |
|
Main ID: |
NCT02609646 |
|
Date of registration:
|
18/11/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
AbioKin - Antibiotic Kinetics
|
|
Scientific title:
|
Antibiotic Pharmacokinetics in Critically Ill Patients |
|
Date of first enrolment:
|
January 2016 |
|
Target sample size:
|
1500 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02609646 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Stefano Finazzi, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mario Negri Institute for Pharmacological Research |
|
|
Name:
|
Elena Garbero, M.Sci |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Mario Negri Institute for Pharmacological Research |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- patients undergoing antibiotic therapy with amikacin, linezolid, meropenem,
piperacillin/tazobactam, or vancomycin.
- patients whose antibiotic therapy started during the stay in ICU or less than 24h
before admission to ICU.
- patients with anticipated length of stay in ICU of at least 24h.
- patients with already-placed catheter
Exclusion Criteria:
- patients undergoing antibiotic prophylaxis
- lack of informed consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Infection
|
|
Critical Illness
|
|
Intervention(s)
|
|
Drug: Piperacillin-tazobactam combination product
|
|
Drug: Vancomycin
|
|
Drug: Linezolid
|
|
Drug: Meropenem
|
|
Primary Outcome(s)
|
|
Drug plasma concentration (concentration-dependent antibiotics)
[Time Frame: 30 min after first dose; immediately before second dose; peak and trough of the same dose in the 2nd day of therapy; peak and trough of the same dose between the 3rd and the 5th day of therapy]
|
|
Drug plasma concentration (time-dependent antibiotics)
[Time Frame: 30 min after first dose; 1 day after first dose; 2 day after first dose; 2 measures between the 3rd and the 8th day of treatment]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|