Elite study.
Completed
- Conditions
- CF pos. pseudomonas infection
- Registration Number
- NL-OMON23558
- Lead Sponsor
- chiron corporated ltdgeneraal de witte laan 19a b52800 mechelen belgie
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Male or female subject > 6 months;
Exclusion Criteria
1. History of aminoglycoside hypersensitivity
symptoms of acute pulmonary disease
invest. drugs within 30 days prior to enrollment;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this study is to estimate the duration of eradication of any strain of P aeruginosa infection during the 27 month study period following TNS treatment of early infection in cystic fibrosis patients.
- Secondary Outcome Measures
Name Time Method 1. To estimate the proportion of subjects free form P aeruginosa at visit 5 with 300 mg twice daily for either 28 days or 56 days<br>to assess the safety of patients in the two treatment arms;<br /><br>2. To assess the proportion of patients requiring hospitalisation for pulmonary exacerbation.