Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) populatio

Conditions: Colistin use in Cystic Fibrosis patients
MedDRA version: 16.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-004987-80-BE

Lead Sponsor: CUB - Hôpital Erasme

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. CF patients aged of > 18 years
2. BMI > 18 kg/m2,
3. P. aeruginosa positive exacerbations,
4. requiring IV antibiotics including 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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. chronic renal insufficiency,
2. pregnancy or lactation,
3. no IV antibiotics in the month prior to inclusion.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1) Prospectively evaluating the safety and the profile tolerance of colistin in adult CF patients;Primary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable;Main Objective: 1) Prospectively evaluating the pharmacokinetics and pharmacodynamics of colistin in adult CF patients infected by multidrug resistant P. aeruginosa in order to propose algorithms for optimizing doses in this patients' population<br>2) Studying in vitro the pharmacodynamics of colistin activity against clinical isolates from the same patients when grown as biofilms as well as the conditions of drug exposure favoring selection of resistance in vitro.

Secondary Outcome Measures