Pharmacokinetic and pharmacodynamic evaluation of linezolid administered intravenously in MRSA-positive, morbidly obese patients with pneumonia.

Phase 1

• Conditions: MRSA-positive, morbidly obese patients with pneumonia; MedDRA version: 14.1Level: LLTClassification code 10053024Term: Pneumonia gram-positive bacterialSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-005127-33-BE
• Lead Sponsor: niversity Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-12
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient age 18 years or more
• BMI >35 (BMI = weight (kg) / height2 (m2))
• Radiographically and clinically documented pneumonia and one of the following:
- the patient is MRSA screen-positive and is as such at high risk for MRSA pneumonia (MIC for linezolid is known or possible to assess)
- the patient has a baseline respiratory tract sample positive for MRSA; MRSA pneumonia is likely
- empiric therapy without linezolid is initiated (no obvious indication for MRSA involvement), but the patient is switched to linezolid therapy once culture results demonstrate MRSA as pathogen. CAVE: the patients must be included in the study prior to the moment the first trough sample must be drawn. As such, patients becoming MRSA-positive after >1 dose of linezolid cannot be included in the study.
• Decision to start treatment with linezolid for at least 3 days (6 doses of 600 mg).
• Patient is colonized or infected with MRSA (at any site) and it must be possible to send a fresh isolate to the central laboratory for microbiology
• Written informed consent by the patient or his/her legal representative.

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Exclusion from participation in the study is left at the discretion of the treating physician.
Contraindications as described in the SmPC may serve as a basis for patient exclusion.

Study & Design

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