Voriconazole study: treatment of chronic endobronchial Aspergillus infection with voriconazole in patients with cystic fibrosis

Completed

• Conditions: Cystic fibrosis (CF), Aspergillus infection; Nutritional, Metabolic, Endocrine; Cystic fibrosis

• Registration Number: ISRCTN35866380
• Lead Sponsor: Erasmus Medical Centre (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Confirmed diagnosis of CF (documented by positive sweat test and/or by positive rectal current measurement, and/or genotype consistent with CF, two positive CF mutations, accompanied with two or more clinical features consistent with the CF phenotype)
2. At least three positive cultures for Aspergillus in the two years prior to the study
3. Positive galactomannan test at the start of the study
4. Older than 2 years of age

Exclusion Criteria

1. Allergy to voriconazole
2. Use of drugs contraindicating use of voriconazole:
2.1. Terfanadine
2.2. Astemizol
2.3. Cisapride
2.4. Pimozide
2.5. Kinidine
2.6. Rifampicide
2.7. Carbamazepine
2.8. Phenobarbital
2.9. Ergotamine alkaloiden
2.10. Sirolimus
3. Use of liposomal amphotericine B
4. Use of high dose prednisone
5. Inability to produce sputum
6. Poor compliance
7. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Is treatment with voriconazole in CF patients with a chronic Aspergillus infection effective?

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration