Prevent Pseudomonas Aeruginosa Colonisation

ISRCTN	ISRCTN19620809
DOI	https://doi.org/10.1186/ISRCTN19620809
Clinical Trials Information System (CTIS)	2008-001769-27
Protocol serial number	7857
Sponsor	Southampton University Hospitals NHS Trust (UK)
Funder	Sparks (UK)

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Amanda Harris
Scientific

University of Southampton Clinical Trials Unit, MP131
Tremona Road
Southampton
SO16 6YD
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled trial to assess the benefits of early use ciprofloxacin versus placebo in children with cystic fibrosis to minimise the risks of chronic infection with pseudomonas aeruginosa
Study acronym	PREPAC
Study objectives	Randomised controlled trial to assess the benefits of early use of ciprofloxacin in children with cystic fibrosis to minimise the risks of chronic infection with pseudomonas aeruginosa. More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7857
Ethics approval(s)	Southampton and South West Hampshire LREC B, August 2008, ref: 08/H0504/110
Health condition(s) or problem(s) studied	Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases
Intervention	Study participants randomised to receive active study medication or placebo at times of onset of viral respiratory tract infections: 1. Active arm: ciprofloxacin suspension 30 mg/kg/day for patients aged 2 - 5 years and 40 mg/kg/day (maximum 1,500 mg/24 hours) in those aged 5 - 14 years in a twice daily dose for 14 days 2. Control arm: placebo (ciprofloxacin diluent without added drug) for 14 days Follow up length: 32 months Study entry: single randomisation only
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ciprofloxacin
Primary outcome measure(s)	Pseudomonas infection, accrual of all study data at end of 32-month trial period.
Key secondary outcome measure(s)	1. Time to first detection of pseudomonas at routine 2-monthly clinic visits using both conventional and molecular biological specimens 2. Number of infective exacerbations needing hospital admission/intravenous treatment 3. Cost-benefit analysis of health care resource utilisation as a result of use of ciprofloxacin 4. Difference in symptom diary recording of lower respiratory symptoms 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 6. Differences in serum enzyme-linked immunosorbent assay (ELISA) assays for pseudomonas between the beginning and end of the study
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	14 Years
Sex	All
Target sample size at registration	45
Key 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
Key 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.
Date of first enrolment	01/12/2009
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Southampton Clinical Trials Unit, MP131

Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

04/10/2017: Publication reference added