MRSA study.

Phase 1

• Conditions: Patients affected by cystic fibrosis and who present an initial infection of MRSA.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-000219-25-IT
• Lead Sponsor: AOU Meyer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-12
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients affected by cystic fibrosis who can demonstrate regular visits to the Tuscan regional center of CF, older than 4 years and not infected by Burkholderia cepacia complex and with no clinical signs of respiratory exacerbation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

CF patients that, at MRSA isolation, show evidence of respiratory exacerbation, history of antibiotic hypersensitivity or adverse reaction to antibiotics, liver cirrhosis or abnormal liver function test results at study entry, abnormal kidney function at study entry, pregnancy, lung/liver transplantation

Study & Design

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