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

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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

This study has been completed.

Study NCT00005668. Last updated on November 11, 2005. Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
Official Title ^†	A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
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.
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 Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Double-Blind, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Aspergillosis Lung Diseases, Fungal
Intervention ^†	Drug: Itraconazole oral solution
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	96
Start Date ^†
Completion Date	November 2005
Eligibility 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: positive test for Aspergillus species. 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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00005668
Organization ID	DMID MSG 37
Secondary IDs ^††	DMID 96-199, NIH/09021
Study Sponsor ^†	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	November 2005
First Received Date ^†	May 18, 2000
Last Updated Date	November 11, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.