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

Information source: The University of Texas Health Science Center at Tyler
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycobacterium Avium Complex Lung Disease

Intervention: clarithromycin, rifabutin (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: The University of Texas Health Science Center at Tyler

Official(s) and/or principal investigator(s):
Richard J Wallace Jr., M.D., Principal Investigator, Affiliation: The University of Texas Health Science Center at Tyler

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

Clinical Details

Official title: 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

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

Primary outcome: Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures

Secondary outcome: To determine if treatment given three times weekly is as effective in producing sputum culture conversion as treatment given daily

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

The University of Texas Health Science Center at Tyler, Tyler, Texas 75708, United States
Additional Information

Starting date: August 1995
Last updated: January 11, 2008

Page last updated: August 23, 2015

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