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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 Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult 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 site devoted 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 healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 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 volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated 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. Test subjects oftentimes receive the most effective 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. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous 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 Aspergillosis Studies:
1. A Safety & Effectiveness Study of Intravenous Anidulafungin with AmBisome® for Treatment of Invasive Aspergillosis (IA).
2. An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
3. Voriconazole vs. Amphotericin B in the Treatment of Invasive Aspergillosis
4. Trial of Micafungin (FK463) in Combination with Liposomal Amphotericin B (AmBisome) for Aspergillosis
5. Study of FK463 for the Treatment of Invasive Aspergillosis
Related Studies:
Other Aspergillosis Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
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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