Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Amanda Harris


Contact details

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

Additional identifiers

EudraCT number

2008-001769-27 number

Protocol/serial number


Study information

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 hypothesis

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:

Ethics approval

Southampton and South West Hampshire LREC B, August 2008, ref: 08/H0504/110

Study design

Single-centre randomised interventional treatment trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases


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



Not Applicable

Drug names


Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants

Planned sample size: 45; UK sample size: 45

Participant 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.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information


Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
SO16 6YD
United Kingdom

Sponsor type

Not defined



Funder type


Funder name

Sparks (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes