A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

NCT00005668 | Completed Phase 2

• 3 other identifiers: DMID MSG 37DMID 96-199NIH/09021
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma. Aspergilloma is a "fungal ball" in the lungs caused by Aspergillus. The infection can spread from the lungs through the blood to other organs. Aspergilloma can be life-threatening; therefore, an effective treatment is needed.

Conditions

Aspergillosis; Lung Diseases, Fungal

Interventions

Itraconazole oral solution DRUG

Eligibility Criteria

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

You may qualify if:

• You may be eligible for this study if you:
• Are 18 years of age or older.
• Have been diagnosed with aspergilloma within the last month.
• Have (or have a history of) at least one of the following:
• positive test for Aspergillus species.
• presence of antibodies to Aspergillus.
• Are willing to participate in the study for 2 full years.
• Are female and not pregnant.
• Are not breast-feeding.
• Agree to use barrier methods of birth control / contraception during the study and for 30 days after.

You may not qualify if:

• You will not be eligible for this study if you:
• Have a history of allergy to triazole or imidazole drugs.
• Are unable to take oral medication.
• Are not expected to live for more than a month.
• Have had a lung biopsy indicating Aspergillus infection.
• Have had radiation therapy within the last 6 months.
• Require treatment with certain medications.
• Received amphotericin, amphotericin lipid formulation, fluconazole, or itraconazole in the two weeks prior to study entry.
• Received chemotherapy within the last 6 months.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Mary Ellen Bradley

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Aspergillosis; Lung Diseases, Fungal

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 18, 2000
• First Posted: August 31, 2001
• Study Completion: November 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2005-11

Locations

US (1)