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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.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00005668
First received: May 18, 2000
Last updated: August 26, 2010
Last verified: November 2005
History of Changes
  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.


Condition Intervention Phase
Aspergillosis
Lung Diseases, Fungal
 Drug: Itraconazole oral solution
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma

Resource links provided by NLM:

MedlinePlus related topics: Aspergillosis Molds
U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 96
Estimated Study Completion Date: November 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005668

Locations
United States, Alabama
Mary Ellen Bradley
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00005668     History of Changes
Other Study ID Numbers: DMID MSG 37, DMID 96-199, NIH/09021
Study First Received: May 18, 2000
Last Updated: August 26, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Aspergillosis
Lung Diseases
Lung Diseases, Fungal
Mycoses
Respiratory Tract Diseases
Respiratory Tract Infections
Itraconazole
Hydroxyitraconazole
 14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013