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Use of Azithromycin and Rifabutin Administered Three Times Weekly 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

Intervention: Azithromycin, 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 efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex

Clinical Details

Official title: Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin 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: Microbiological cultures

Eligibility

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

Criteria:

Inclusion Criteria:

- Meet American Thoracic Society criteria for nontuberculous 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; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).

- Age 18 and older

- Pretreatment isolate of M. avium complex available for MIC determination

- Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver

enzymes), hearing test, visual acuity and color discrimination

- Available for long term followup

Exclusion Criteria:

- History of macrolide or rifamycins allergy

- Laboratory evidence of mycobacterial resistance to azithromycin

- Children less than 18 years of age

- If a menstruating female, not pregnant and on adequate birth control

- HIV+ or at risk

Locations and Contacts

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

Starting date: December 1994
Last updated: January 11, 2008

Page last updated: August 23, 2015

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