Expired Study
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Birmingham, Alabama 35294


Purpose:

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.


Study summary:

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


Criteria:

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.


NCT ID:

NCT00005668


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Birmingham, Alabama 35294
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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