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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 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma Clinical research trials and A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma. A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma clinical trial. Subjects frequently get the best healthcare possible for their A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma  A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
For Condition: Aspergillosis,Lung Diseases, Fungal
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo (oral cyclodextrin solution) twice daily for 12 months.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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: a) positive test for Aspergillus species. b) 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.
Total Enrollment: 96
Location and Contact Information:
Mary Ellen Bradley
Birmingham, Alabama, 35294
United States
Additional Information:
Study ID Numbers: DMID MSG 37; NIH/09021,DMID 96-199
Study Start Date:
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005668
Other Lung Diseases, Fungal Studies:
1. A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
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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
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