drugset / Trial / NCT01576315

ATCF (Azole Therapy in Cystic Fibrosis)

NCT01576315

Phase 2 Completed 11 enrolled Rennes University Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

Aspergillus infection is an infectious complication which frequently occurs in cystic fibrosis. The efficacy of azole therapy in patients with cystic fibrosis with persistent positive sputums for Aspergillus is still unknown. Furthermore, the efficacy of itraconazole and voriconazole in this indication has never been evaluated in a large prospective controlled clinical trial, even though many teams already use it. The ATCF study aims to assess in patients with cystic fibrosis with persistent Aspergillus positive cultures the efficacy of itraconazole and voriconazole on the negativisation of the sputum cultures for Aspergillus.

Timeline

Start
2014-06
Primary completion
2015-10
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 100 mg Oral
Subject Itraconazole Small molecule 200 mg Oral
Subject Voriconazole Small molecule 100 mg Oral
Subject Voriconazole Small molecule 200 mg Oral