An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF
- Conditions
- Adult patients with cystic fibrosisMedDRA version: 8.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
- Registration Number
- EUCTR2006-006362-41-GB
- Lead Sponsor
- eeds Teaching Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
•Confirmed cystic fibrosis according to the US Cystic Fibrosis Foundation guidelines
•Male or female subjects aged between 18 and 40 years;
•Hospitalised subject requiring routine intravenous antibiotic treatment;
•Written informed consent has been obtained;
•Pancreatic insufficiency as determined by a faecal elastase of <100µg g-1
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
•Known history or suspicion of alcohol or drug abuse;
•Pregnancy or breast-feeding female;
•Female subject of childbearing potential without adequate contraception;
•Participation in an investigational drug trial in the 30 days prior to selection;
•Known hypersensitivity to voriconazole or other azole (Fluconazole, Itraconazole, Ketoconazole, Ravuconazole, Posaconazole) antifungal agents;
•Known history of severe drug allergy or hypersensitivity;
•Has received systemic voriconazole within two weeks before study entry;
•Is receiving treatment with drugs that are contraindicated (See Concomitant therapy);
•Weight of less than 40kg
•Has liver disease defined as liver enzymes > twice the upper normal limit or bilirubin > 50mmol/l at trial entry;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method