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

NCT00528190 | Completed Phase 4 Results DMC

• 1 other identifier: 2006768
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Aspergillus Fumigatus; randomized controlled clinical trials

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome Measure Will be the Number of Patients Who Experience a Respiratory Exacerbation Requiring Intravenous Antibiotics in the Two Treatment Groups Over the 24 Week Trial Treatment Period.

  The Primary outcome measure will be the number of patients who experience a respiratory exacerbation requiring intravenous antibiotics in the two treatment groups over the 24 week trial treatment period.

  24 weeks

Study Arms (2)

Itraconazole

EXPERIMENTAL

Itraconazole 5mg/kg/day for 24 weeks

Drug: Itraconazole

Placebo

PLACEBO COMPARATOR

Placebo/day for 24 weeks

Drug: Itraconazole

Interventions

Itraconazole DRUG

Oral Itraconazole 5mg/kg/day or identical placebo for 24 weeks

Also known as: non applicable

Itraconazole; Placebo

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
• Patient must be known to be chronically colonized with Aspergillus fumigatus.
• Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization.
• years of age and older
• Patients must weigh at least 20 kg
• Post-menarche females must be using an effective form of contraception.

You may not qualify if:

• Inability to give informed consent.
• Respiratory culture positive for B.cepacia complex
• Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization
• Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization
• Neutropenia, absolute neutrophil count\< or = 1000 within a 3-day period prior to randomization
• History of biliary cirrhosis documented by liver biopsy or imaging.
• History of portal hypertension.
• Investigational drug use within 30 days of randomization date.
• History of alcohol, illicit drug or medication abuse within 1 year of randomization.
• Women who are pregnant, breastfeeding or trying to conceive

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Hospital for Sick Children: collaborator
• Canadian Cystic Fibrosis Foundation: collaborator
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (2)

Shawn Aaron, The Ottawa Hospital-General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Felix Ratjen, The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

• 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.

  PMID: 22563440 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Shawn Aaron
• Organization: Ottawa Hospital Research Institute

saaron@ohri.ca

613-737-8259

Study Officials

• Shawn Aaron, MD

  OHRI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 12, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: May 1, 2011
• Last Updated: May 10, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)