Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by The University of Texas Health Science Center at Tyler.
Recruitment status was Active, not recruiting

Sponsor:

Collaborators:

Abbott

Pfizer

Information provided by:

The University of Texas Health Science Center at Tyler

ClinicalTrials.gov Identifier:

NCT00598897

First received: January 11, 2008

Last updated: NA

Last verified: January 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

January 11, 2008

Last Updated Date

January 11, 2008

Start Date ^ICMJE

August 1995

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation at one month, then at three months, then at 6 months, then annually, and prn for life ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

To determine if treatment given three times weekly is as effective in producing sputum culture conversion as treatment given daily [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation at one month, then at three months, then at 6 months, then annually, and prn for life ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

Official Title ^ICMJE

Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease

Brief Summary

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Mycobacterium Avium Complex Lung Disease

Intervention ^ICMJE

Drug: clarithromycin, rifabutin

Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.

Other Names:

Biaxin
Mycobutin

Study Arm (s)

Intervention: Drug: clarithromycin, rifabutin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
Adults age 18 and older
Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

History of allergy to study drugs
If a mensruating female, not pregnant and on adequate birth control.
Children less than 18 years of age
HIV + or at high risk for HIV infection.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00598897

Other Study ID Numbers ^ICMJE

447

Has Data Monitoring Committee

Responsible Party

Richard J. Wallace Jr., M.D., The University of Texas Health Science Center at Tyler

Study Sponsor ^ICMJE

The University of Texas Health Science Center at Tyler

Collaborators ^ICMJE

Abbott
Pfizer

Investigators ^ICMJE

Principal Investigator:

Richard J Wallace Jr., M.D.

The University of Texas Health Science Center at Tyler

Information Provided By

The University of Texas Health Science Center at Tyler

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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