Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
16/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H.A.W.M. Tiddens

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children’s Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636363
h.tiddens@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR359

Study information

Scientific title

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Voriconazole

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/03/2005

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

30/03/2005

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Industry

Funder name

Pfizer (The Netherlands)

Alternative name(s)

Pfizer Inc.

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes