Prevent Pseudomonas Aeruginosa Colonisatio

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 45

Inclusion Criteria

1. Confirmed diagnosis of cystic fibrosis and attending the regional CF service for care exclusively at Southampton or at Southampton and Winchester or Poole General Hospitals
2. Aged 2 - 14 years, either sex
3. Negative ELISA serology for P. aeruginosa at study entry
4. Not chronically infected with pseudomonas aeruginosa

Exclusion Criteria

1. Positive pseudomonas serology on ELISA testing
2. Any other evidence suggesting chronic P. aeruginosa infection
3. Chronic infection with any other gram negative CF pathogen
4. Past history of allergic reaction or any other significant adverse reaction to previous treatment with oral ciprofloxacin
5. Ongoing participation any other clinical trial at time of study entry
6. Parents or guardians unwilling to give informed consent for study inclusion
7. Patients who have a recognised indication for other antibiotics
8. Immunosuppressive/immunomodulatory therapy
9. Significant immunocompromise (e.g., human immunodeficiency virus [HIV] infection)
10. Advanced malignancy
11. Burns
12. Children not likely to survive the time period of the intervention
13. Patients who have undergone organ transplantation (including bone marrow transplantation)
14. Patients undergoing plasma exchange or whole blood exchange transfusion
15. Treatment with an investigational drug or device within the last 30 days prior to enrolment
16. Immediate families of investigators or site personnel directly affiliated with the study. Immediate family is defined as child or sibling, whether biological or legally adopted.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pseudomonas infection, accrual of all study data at end of 32-month trial period.

Secondary Outcome Measures

Name	Time	Method
1. Time to first detection of pseudomonas at routine 2-monthly clinic visits using both conventional and molecular biological specimens<br>2. Number of infective exacerbations needing hospital admission/intravenous treatment<br>3. Cost-benefit analysis of health care resource utilisation as a result of use of ciprofloxacin<br>4. Difference in symptom diary recording of lower respiratory symptoms<br>5. Conventional and molecular microbiological data will also be explored to determine the relationship between specific viral infections and the occurrence of P. aeruginosa at the time of acute viral infection<br>6. Differences in serum enzyme-linked immunosorbent assay (ELISA) assays for pseudomonas between the beginning and end of the study