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Voriconazole study.


- candidate number1568
- NTR NumberNTR359
- ISRCTNISRCTN35866380
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleVoriconazole study.
- Scientific TitleTreatment of chronic endobronchial Aspergillus infection with voriconazole in patients with Cystic fibrosis.
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Aspergillus infection
- Inclusion criteria1. 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 criteria1. 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 alkalo´den;
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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-mrt-2005
- planned closingdate31-dec-2006
- Target number of participants20
- Interventions7x sputumculture;
7x urine collection;
7x bloodsample;
7x lungfunction;
1x pregnancytest.
- Primary outcomeIs treatment with voriconazole in cf patients with a chronic Aspergillus infection effective?
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. H.A.W.M. Tiddens
- CONTACT for SCIENTIFIC QUERIESDr. H.A.W.M. Tiddens
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Pfizer
- PublicationsN/A
- Brief summaryChronic 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)
- RECORD12-sep-2005 - 14-sep-2009


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