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
  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:


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
  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 April 16, 2014