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| [ Print-friendly version ] |
| Voriconazole study: treatment of chronic endobronchial Aspergillus infection with voriconazole in patients with cystic fibrosis |
| ISRCTN | ISRCTN35866380 |
| ClinicalTrials.gov identifier | |
| Public title | Voriconazole study: treatment of chronic endobronchial Aspergillus infection with voriconazole in patients with cystic fibrosis |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | NTR359 |
| Study hypothesis |
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 cystic fibrosis (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. The objective of this trial is to use voriconazole to treat patients with chronic endobronchial Aspergillus infection and CF. |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Randomised double blinded, placebo controlled, parallel group trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Cystic fibrosis (CF), Aspergillus infection |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 30/03/2005 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 20 |
| Interventions |
Voriconazole versus placebo.
Analyses: 1. 7 x sputum culture 2. 7 x urine collection 3. 7 x blood sample 4. 7 x lung function 5. 1 x pregnancy test |
| Primary outcome measure(s) | Is treatment with voriconazole in CF patients with a chronic Aspergillus infection effective? |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Pfizer (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr H.A.W.M. Tiddens |
| Address |
Erasmus Medical Center
Sophia Children’s Hospital Rotterdam Department of Pediatric Pulmonology Dr. Molewaterplein 60 |
| City/town | Rotterdam |
| Zip/Postcode | 3015 GJ |
| Country | Netherlands |
| Tel | +31 (0)10 4636363 |
| Fax | +31 (0)10 4636801 |
| h.tiddens@erasmusmc.nl | |
| Sponsor | Erasmus Medical Centre (The Netherlands) |
| Address |
Sophia Children's Hospital
Dr. Molewaterplein 60 |
| City/town | Rotterdam |
| Zip/Postcode | 3015 GJ |
| Country | Netherlands |
| Sponsor website: | http://www.erasmusmc.nl/content/englishindex.htm |
| Date applied | 19/12/2005 |
| Last edited | 16/09/2008 |
| Date ISRCTN assigned | 19/12/2005 |
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