Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis

Phase 4 Completed 35 enrolled Ottawa Hospital Research Institute Canadian Cystic Fibrosis Foundation · collab The Hospital for Sick Children · collab The Physicians' Services Incorporated Foundation · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This clinical trial will attempt to determine whether we can improve clinical outcomes for patients with cystic fibrosis who are infected with a fungus called Aspergillus fumigatus.

Timeline

Start: 2007-10
Primary completion: 2010-08
Completion: 2011-05

Outcome

Missed primary endpoint

paper 4 of 18 (22%) patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31%) placebo treated patients, P = 0.70. PMID 22563440 ↗

Publications

Aaron SD, Vandemheen KL, Freitag A, Pedder L, Cameron W, Lavoie A, Paterson N, Wilcox P, Rabin H, Tullis E, Morrison N, Ratjen F. Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study. PLoS One. 2012;7(4):e36077. doi: 10.1371/journal.pone.0036077. Epub 2012 Apr 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	5 mg/kg	Oral