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

ISRCTN	ISRCTN35866380
DOI	https://doi.org/10.1186/ISRCTN35866380
Protocol serial number	NTR359
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Pfizer (The Netherlands)

Submission date: 19/12/2005
Registration date: 19/12/2005
Last edited: 16/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H.A.W.M. Tiddens
Scientific

Erasmus Medical Center
Sophia Childrens Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Phone	+31 (0)10 4636363
Email	h.tiddens@erasmusmc.nl

Study information

Primary study design	Interventional
Study design	Randomised double blinded, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Cystic fibrosis (CF), Aspergillus infection
Intervention	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
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Voriconazole
Primary outcome measure(s)	Is treatment with voriconazole in CF patients with a chronic Aspergillus infection effective?
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	30/03/2005
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Center

Rotterdam
3015 GJ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan