Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.

• Conditions: Cystic fibrosis patients with early P.aeruginosa infection.; MedDRA version: 14.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-006171-19-IT
• Lead Sponsor: AZIENDA OSPEDALIERA MEYER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-13
• Last Update Posted: 3 July 2012

Recruitment & Eligibility

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

Inclusion Criteria

-Patients with cystic fibrosis disease
-regular frequency in the CF centers
-sensibility of P. aeruginosa to the sperimental therapy
-patients over 5 years
-patients with early infection from P. aeruginosa without clinical signs of respiratory exacerbation
Are the trial subjects under 18? yes
Number of subjects for this age range: 65
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-intermittent or chronic infection from P. aeruginosa
-history of adverse events to the RCT
treatment
-earing failure, liver and renal disfunctions
-macrolid used in the 3 months before the RCT

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare between 2 different antibiotics protocols (oral cyprofloxacin and inhaled promixin vs oral cyprofloxacin and inhaled tobramycin) for the eradication of early P. aeruginosa infection in patients with cystic fibrosis disease.;Secondary Objective: -evaluation of the hematic antibody answer<br>- evaluation of the respiratory functionality tests (FEV1)<br>-evaluation of the growth BMI, of the of relapses number, and of the antibiotic's use.;Primary end point(s): Eradication of early infection;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -evaluation of the hematic antibody answer<br>- evaluation of the respiratory functionality tests (FEV1)<br>-evaluation of the growth BMI, of the of relapses number, and of the antibiotic's use.;Timepoint(s) of evaluation of this end point: 2 years