Prevent Pseudomonas Aeruginosa Colonisation
| ISRCTN | ISRCTN19620809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19620809 |
| EudraCT/CTIS number | 2008-001769-27 |
| Secondary identifying numbers | 7857 |
- 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
Scientific
University of Southampton Clinical Trials Unit, MP131
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Single-centre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ciprofloxacin |
| Primary outcome measure | Pseudomonas infection, accrual of all study data at end of 32-month trial period. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/12/2009 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 45; UK sample size: 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
- England
- United Kingdom
Study participating centre
University of Southampton Clinical Trials Unit, MP131
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Sponsor information
Southampton University Hospitals NHS Trust (UK)
Not defined
Not defined
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Website | http://www.soton.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
Funders
Funder type
Charity
Sparks (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Sparks Charity
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
04/10/2017: Publication reference added
