E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis.
I have included the ICD classification for chest infection below. |
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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 |
1. Main question: Why do patients with cystic fibrosis have a higher incidence of light-induced rashes when they take the antibiotic ciprofloxacin compared to patients who do not have cystic fibrosis?
(The phototoxic potential of ciprofloxacin has been reported to be mild and the incidence low (less than 2.4%). The incidence of phototoxic rashes in patients with cystic fibrosis appears to be increased - 16-52% as quoted in the literature. A questionnaire-based study involving cystic fibrosis patients at Belfast City Hospital revealed an incidence of 35.5% of clinical photosensitive rashes with ciprofloxacin). |
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E.2.2 | Secondary objectives of the trial |
1. It is planned to determine the incidence of light -induced rashes in cystic fibrosis patients taking the antibiotic ciprofloxacin by using a detailed questionnaire.
2. The objective relevant to this application is to reproduce the rashes by shining light of different strengths onto the skin of patients with and without cystic fibrosis before and after taking the antibiotic ciprofloxacin (750mg twice daily for two days).
3. It is then planned to take skin samples from patients with and without cystic fibrosis to address the following question: Are the skin cells exposed to ciprofloxacin in cystic fibrosis patients more susceptible to damage by light than cells from patients without cystic fibrosis and if so, what are the mechanisms behind the damage? |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
CASESS: 1. Adult patients (over 18 years old)with cystic fibrosis 2. Pateitns have not had a course of ciprofloxacin in the past 2 months
CONTROLS: 1. Adult patients (over 18 years old) 2. Patients have not had a course of ciprofloxacin in the past 2 months |
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E.4 | Principal exclusion criteria |
CASES AND CONTROLS: 1.Allergy to ciprofloxacin 2. Hypersensitivity to ultraviolet light 3. History of skin cancer 4. Pregnancy 5. Previous phototherapy in past 3 months 6. Current history of immunosupression |
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E.5 End points |
E.5.1 | Primary end point(s) |
Each patient will undergo light testing before and after taking ciprofloxacin (1g twice daily for two days). Different strengths and wavelengths of light will be applied to the patients skin. They will return after 24 hours for analysis. The strength of light that causes redness at various wavelengths will be recorded (main end point). The phototoxic index will then be calculated: dose of light causing redness whilst taking ciprofloxacin divided by dose of light causing redness while not taking ciprofloxacin. This figure will then be used in the statistical analysis. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | Information not present in EudraCT |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
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 | Information not present in EudraCT |
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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The end of the trial will be that time when all cases and controls will have undergone light testing before and after taking ciprofloxacin and the phototoxic index has been calculated for each patient. The patients will be no longer required to attend the department for research purposes. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |