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.
Conditions
Interventions
Trade Name: Ciprofloxacin (ciproxin)
Product Name: N/A
Product Code: N/A
Pharmaceutical Form: Coated tablet
Sponsors
Belfast City Hospital Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). ; Secondary Objective: 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? ;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 | — |
Countries
United Kingdom
Outcome results
None listed