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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT00005668
Collaborator
(none)
96
Enrollment
1
Location

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Itraconazole oral solution
 Phase 2

Detailed Description

Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.

Study Design

Study Type:
Interventional
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    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:

    1. positive test for Aspergillus species.

    2. 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.

    Exclusion Criteria:
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mary Ellen Bradley Birmingham Alabama United States 35294

    Sponsors and Collaborators

    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00005668
    Other Study ID Numbers:
    • DMID MSG 37
    • DMID 96-199
    • NIH/09021
    First Posted:
    Aug 31, 2001
    Last Update Posted:
    Aug 27, 2010
    Last Verified:
    Nov 1, 2005
    Additional relevant MeSH terms:
    Aspergillosis
    Mycoses
    Lung Diseases, Fungal
    Lung Diseases
    Itraconazole

    Study Results

    No Results Posted as of Aug 27, 2010