Voriconazole study: treatment of chronic endobronchial Aspergillus infection with voriconazole in patients with cystic fibrosis
| ISRCTN | ISRCTN35866380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35866380 |
| Secondary identifying numbers | NTR359 |
- 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
Scientific
Erasmus Medical Center
Sophia Childrens Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636363 |
|---|---|
| h.tiddens@erasmusmc.nl |
Study information
| Study design | Randomised double blinded, placebo controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Voriconazole |
| Primary outcome measure | Is treatment with voriconazole in CF patients with a chronic Aspergillus infection effective? |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/03/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
3015 GJ
Netherlands
Sponsor information
Erasmus Medical Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Industry
Pfizer (The Netherlands)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
