Respiratory infections with Pseudomonas aeruginosa in children with Cystic Fibrosis; early surveillance and preventio

Completed

• Conditions: Nutritional, Metabolic, Endocrine; Pulmonary P. aeruginosa infection, cystic fibrosis; Cystic fibrosis

• Registration Number: ISRCTN11604593
• Lead Sponsor: niversity Medical Center Utrecht (UMCU) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. CF diagnosis as confirmed by sweat chloride test and/or genotyping
2. Aged less than 18 years old
3. No evidence of P. aeruginosa in cultures taken in period 2004 - 2005
4. Antibody titer less than 1:1250 for three antigens of P. aeruginosa
5. No regular treatment against P. aeruginosa
6. Informed consent

Exclusion Criteria

1. Aged greater than 18 years
2. P. aeruginosa in cultures after 2003
3. Participating in another trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early P. aeruginosa colonisation as confirmed by: <br>1. Persistence of P. aeruginosa in sputum or oropharygeal swab culture in two consecutive samples, taken greater than 3 days apart<br>2. P. aeruginosa in one oropharyngeal swab or sputum culture with pulmonary exacerbation

Secondary Outcome Measures

Name	Time	Method
Microbiological:<br>1. Age at first positive culture<br>2. Time to P. aeruginosa colonisation<br>3. Respiratory pathogens in culture<br>4. Resistance pattern of respiratory pathogens<br><br>Serological:<br>5. Seroconversion for anti-pseudomonal antibodies<br><br>Clinical: <br>6. Adverse events<br>7. Clinical parameters (lung function, body weight and chest radiograph scores, inflammation parameters)<br>8. Number of pulmonal exacerbations<br>9. Antimicrobial agent use