Metabolisation and efficiency study of colistin in critically ill patients

Phase 1

• Conditions: Patients in intensive care unit suffering of infection by multi-drug resistance bacteria treated by colistin; MedDRA version: 18.0Level: HLTClassification code 10040054Term: Sepsis, bacteraemia, viraemia and fungaemia NECSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-003708-22-BE
• Lead Sponsor: Hospital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-14
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-age > 18 years
-infection by multidrug resistant Gram negative bacteria
-treatment by colistin
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-age < 18 years
-pregnant or breast feeding

Study & Design

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