Respiratory infections with Pseudomonas aeruginosa in children with Cystic Fibrosis; early surveillance and prevention.
Completed
- Registration Number
- NL-OMON25471
- Brief Summary
A controlled trial of cycled antibiotic prophylaxis to prevent initial Pseudomonas aeruginosa infection in children with cystic fibrosis.<br> G.A. Tramper-Stranders, T.F.W. Wolfs, S. van Haren Noman, W.M.C. van Aalderen, A.F. Nagelkerke, M. Nuijsink, J.L.L. Kimpen, C.K. van der Ent.<br> Thorax 2010 Oct;65:915-20
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. CF diagnosis as confirmed by sweat chloride test and/or genotyping;
2. Age< 18 y;
Exclusion Criteria
1. Age > 18 years;
2. P. aeruginosa in cultures after 2003;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early P. aeruginosa colonization as confirmed by <br /><br>-persistence of P. aeruginosa in sputum or oropharygeal swab culture in two consecutive samples, taken > 3 days apart;<br /><br>-P. aeruginosa in one oropharyngeal swab or sputum culture with pulmonary exacerbation.
- Secondary Outcome Measures
Name Time Method MICROBIOLOGICAL:<br /><br>1. Age at first positive culture;<br /><br>2. Time to P. aeruginosa colonisation;<br /><br>3. Respiratory pathogens in culture; <br /><br>4. Resistance pattern of respiratory pathogens.<br /><br><br>SEROLOGICAL:<br /><br>5. Seroconversion for anti-pseudomonal antibodies;<br /><br><br>CLINICAL: <br /><br>6. Adverse events; <br /><br>7. Clinical parameters (lung function, body weight and chest radiograph scores, inflammation parameters); <br /><br>8. Number of pulmonal exacerbations;<br /><br>9. Antimicrobial agent use.