No registrations found.
ID
Source
Brief title
Health condition
CF patients with Aspergillus infection.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Is treatment with voriconazole in cf patients with a chronic Aspergillus infection effective?
Secondary outcome
N/A
Background summary
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 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.
Study objective
N/A
Study design
N/A
Intervention
7x sputumculture;
7x urine collection;
7x bloodsample;
7x lungfunction;
1x pregnancytest.
Dr. Molewaterplein 60
H.A.W.M. Tiddens
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636690 / +31 (0)10 4636363 (general)
h.tiddens@erasmusmc.nl
Dr. Molewaterplein 60
H.A.W.M. Tiddens
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636690 / +31 (0)10 4636363 (general)
h.tiddens@erasmusmc.nl
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.
Exclusion criteria
1. 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 alkaloïden;
k. Sirolimus;
3. Use of liposomal Amphotericine B;
4. Use of high dose Prednisone;
5. Inability to produce sputum;
6. Poor compliance;
7. Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL321 |
| NTR-old | NTR359 |
| Other | : N/A |
| ISRCTN | ISRCTN35866380 |