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

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.

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00005668

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 II

MedlinePlus related topics:

Molds

Drug Information available for:

Itraconazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Double-Blind, Safety/Efficacy Study

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

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

Study ID Numbers:	DMID MSG 37, DMID 96-199, NIH/09021
First Received:	May 18, 2000
Last Updated:	November 11, 2005
ClinicalTrials.gov Identifier:	NCT00005668
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Mycoses

Respiratory Tract Infections

Respiratory Tract Diseases

Clotrimazole

Miconazole

Lung Diseases

Tioconazole

Aspergillosis

Hydroxyitraconazole

Itraconazole

Lung Diseases, Fungal

Additional relevant MeSH terms:

Anti-Infective Agents

Antiparasitic Agents

Antiprotozoal Agents

Therapeutic Uses

Antifungal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008