Microbiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC

• Conditions: Cystic FibrosisSpecifically 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.

• Registration Number: EUCTR2008-001769-27-GB
• Lead Sponsor: Southampton University Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified