| - candidate number | 1568 |
| - NTR Number | NTR359 |
| - ISRCTN | ISRCTN35866380 |
| - Date ISRCTN created | 19-dec-2005 |
| - date ISRCTN requested | 28-okt-2005 |
| - Date Registered NTR | 12-sep-2005 |
| - Secondary IDs | N/A |
| - Public Title | Voriconazole study. |
| - Scientific Title | Treatment of chronic endobronchial Aspergillus infection with voriconazole in patients with Cystic fibrosis. |
| - ACRONYM | N/A |
| - hypothesis | N/A |
| - Healt Condition(s) or Problem(s) studied | Cystic Fibrosis (CF), Aspergillus infection |
| - 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; a. Voriconazole; b. Terfanadine; c. Astemizol; d. Cisapride; e. Pimozide; f. Kinidine; g. Rifampicide; h. Carbamazepine; i. Fenobarbital; j. Ergotamine alkaloïden; k. Sirolimus; 3. Use of liposomal Amphotericine B; 4. Use of high dose Prednisone; 5. Inability to produce sputum; 6. Poor compliance; 7. Pregnancy. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 30-mrt-2005 |
| - planned closingdate | 31-dec-2006 |
| - Target number of participants | 20 |
| - Interventions | 7x sputumculture; 7x urine collection; 7x bloodsample; 7x lungfunction; 1x pregnancytest. |
| - Primary outcome | Is treatment with voriconazole in cf patients with a chronic Aspergillus infection effective? |
| - Secondary outcome | N/A |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | Dr. H.A.W.M. Tiddens |
| - CONTACT for SCIENTIFIC QUERIES | Dr. H.A.W.M. Tiddens |
| - Sponsor/Initiator | Erasmus Medical Center, Sophia Children's Hospital |
| - Funding (Source(s) of Monetary or Material Support) | Pfizer |
| - Publications | N/A |
| - Brief summary | Chronic infection with fungi seems to play an important role in the structural lung damage caused by inflammation. A correlation between Aspergillus specific IgG antibodies in the blood of CF patients and severity and extension of bronchiectasis was recently found in the CF-population treated at the Erasmus-MC. Chronic infection with Aspergillus is seen in as much as 20% of CF patient of 5 years and older (Australian database, database CF-population Erasmus-MC/Sophia). These patients have positive sputum cultures for Aspergillus. The prevalence of chronic fungal infection seems to be increasing since the introduction of nebulised antibiotic treatment for Pseudomonas infection. An effective treatment for chronic Aspergillus infection has not yet been found. |
| - Main changes (audit trail) | |
| - RECORD | 12-sep-2005 - 14-sep-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl