E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Children will remain in the study for a 32 month period commencing after their randomisation to active or placebo groups at the time of their first respiratory infection after recruitment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |