Azole Therapy in Cystic Fibrosis (ATCF)

• Conditions: Cystic fibrosis; MedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: HLTClassification code 10003486Term: Aspergillus infectionsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-005799-41-GB
• Lead Sponsor: CHU de Rennes (Rennes University Hospital Centre)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-21
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- age greater than or equal to 18 years,
- patient with cystic fibrosis,
- presenting with a positive sputum culture for Aspergillus confirmed
twice : within 6 months entry and within 2 weeks of inclusion
- Written informed consent for adult patients.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

- patients with a contraindication to one of the antifungal agents
evaluated,
- pregnant women or nursing mothers,
- absence of an effective method of contraception in women of childbearing
potential,
- patients with signs or symptoms of invasive aspergillosis,
- patients with signs or symptoms of aspergilloma,
- patients with an infection caused by Burkholderia Cepacia complex or
mycobacteria,
- lung transplant patients, registered on a transplantation waiting list or
whose registration is imminent,
- patients who received systemic antifungal therapy for more than 5
days within 2 months prior to inclusion,
- patients currently enrolled in another clinical drug trial,
- ongoing treatment with medicinal products contraindicated with
itraconazole and voriconazole or with major interactions which reduce
azole concentrations,
- patients treated by medication known to prolong QT interval, or with
known prolongation of QTc interval > 450 msec in men and > 470 msec
in women,
- inability to follow or to understand the study procedures.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified