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Voriconazole study.

Treatment of chronic endobronchial Aspergillus infection with voriconazole in patients with Cystic fibrosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28850
Enrollment
20
Registered
2005-09-12
Start date
2005-03-30
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CF patients with Aspergillus infection.

Interventions

7x lungfunction
1x pregnancytest.
7x sputumculture
7x urine collection
7x bloodsample

Sponsors

erasmusmc sophia
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Is treatment with voriconazole in cf patients with a chronic Aspergillus infection effective?

Contacts

Public ContactH.A.W.M. Tiddens

Erasmus Medical Center, Sophia Children’s Hospital Rotterdam, Department of Pediatric Pulmonology, Dr. Molewaterplein 60

h.tiddens@erasmusmc.nl+31 (0)10 4636690 / +31 (0)10 4636363 (general)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)