Cystic Fibrosis Specifically the trial will include children aged 2-14 years with a diagnosis of cystic fibrosis and not chronically infected with pseudomonas aeruginosa in their lungs.
Conditions
Interventions
Trade Name: Ciproxin Suspension
Product Name: Ciproxin
Product Code: PL 0010/0211
Pharmaceutical Form: Oral suspension
Pharmaceutical form of the placebo: Oral solution
Route of administration of the
Sponsors
Southampton University Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of Cystic Fibrosis and attending the regional CF service for care exclusively at Southampton or at both Southampton and Poole General Hospitals. 2. Aged 2-14 years 3. Negative ELISA serology for P. aeruginosa at study entry. 4. Not chronically infected with pseudomonas aeruginosa. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 (eg 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary clinical outcome measure will be the difference in the percentage of positive isolates of pseudomonas aeruginosa obtained as part of routine clinical care during the 3 year study period between children receiving oral ciproxin or placebo for treatment of acute respiratory infections. ;Secondary Objective: Secondary outcome measures will include: 1. Time to first detection of pseudomonas at routine 2 monthly clinic visits using both conventional and molecular biological specimens. 2. Numbers of P. aeruginosa detected by conventional and molecular biological testing at 2 weeks after taking study medication. 3. Number of infective exacerbations needing hospital admission/intravenous treatment 4. Cost benefit analysis of health care resource utilisation as a result of the use of ciprofloxacin 5. Difference in symptom diary recording of lower respiratory symptoms. 6. 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. 7. Differences in serum ELISA assays for pseudomonas between the beginning and end of the study ;Primary end point(s): The primary end point will be between group differences in the percentage of positive isolates of P. aeruginosa at routine clinic visits. Secondary endpoints will explore differences in symptoms and the need for additional therapy | — |
Countries
United Kingdom
Outcome results
None listed