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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25471

Enrollment

100

Registered

2005-07-12

Start date

2005-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

3-monthly courses of 3 weeks, total study duration 3 years.

Ciprofloxacin 10 mg/kg po. or matching placebo bid & colistin 1 MIU inhalation or matching placebo bid

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Age > 18 years; 2. P. aeruginosa in cultures after 2003; 3. Participating in another trial.

Design outcomes

Primary

Measure	Time frame
Early P. aeruginosa colonization as confirmed by -persistence of P. aeruginosa in sputum or oropharygeal swab culture in two consecutive samples, taken > 3 days apart; -P. aeruginosa in one oropharyngeal swab or sputum culture with pulmonary exacerbation.	—

Secondary

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

Measure

Time frame

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

—

Contacts

Public ContactGerdien A. Tramper-Stranders

University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ), KH.01.419.0 P.O. Box 85090

g.tramper@umcutrecht.nl+31 (0)30 2504000

Outcome results