Pharmacokinetics of small spectcrum beta-lactam antibiotics (Amoxicillin/Clavulanic Acid and Cefuroxime) on intensive care.

Phase 1

• Conditions: Patients who are hospitalised on the Intensive Care Unit, and who are treated with Amoxicillin/Clavulanic acid or Cefuroxime, because of an infection.; MedDRA version: 14.1Level: LLTClassification code 10053349Term: Pharmacokinetic studySystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-006107-35-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-15
• Study Completion: 2014-01-21
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

- patients, hospitalised on the Intensive Care
- treatment with Amoxicillin/Clavulanic acid or Cefuroxime, because of an infection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- patients < 18 years of age
- no signed informed consent
- Hematocrite < 21%
- no arterial catheter present

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the pharmacokinetics of Amoxicillin/clavulanic acid and Cefuroxime.;Secondary Objective: To promote the use of small spectrum beta-lactam antibiotics.;Primary end point(s): PK analysis.;Timepoint(s) of evaluation of this end point: After 360 minutes (for amoxilline/clavulanic acid) and 480 minutes (for cefuroxime) after minimum 24 hours under antibiotics therapy.