Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007
- Conditions
- Cystic fibrosisMedDRA version: 9.1Level: SOCClassification code 10038738
- Registration Number
- EUCTR2008-006502-42-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA MEYER
- 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
CF patients with new P. aeruginosa colonisation
Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
pulmonary exacerbation, chronic infection by Gram negative roads
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary aim of the study is to statistically compare, on a large sample of patients affected with CF and by means of a multicentre randomised trial, the efficacy of two types of eradication treatment (ciproflaxin per os and inhaled tobramycin compared to ciproflaxin per os and inhaled colistin) against a first P. aeruginosa infection.;Secondary Objective: microbiological and clinical evolution;Primary end point(s): to evaluate the effectiveness of 2 types of treatment
- Secondary Outcome Measures
Name Time Method