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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)

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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:

    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.
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.




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