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.


Study is Available At:


Original ID:

DMID MSG 37


NCT ID:

NCT00005668


Secondary ID:

DMID 96-199


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, M


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

96


Enrollment Type:


Study Dates

Completion Date:November 2005
Verification Date:November 2005
Last Changed Date:August 26, 2010
First Received Date:May 18, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Itraconazole oral solution

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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