Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

The University of Texas Health Science Center at Tyler210 enrolled

Overview

Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria

Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Nontuberculous Mycobacteria Mycobacterium Avium Complex

Interventions

ClarithromycinDRUG

Dosage dependent on clinical factors such as age, weight and patient-specific health status

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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; absence of other potential lung pathogens (except for the coexistence of M. abscessus) * Age 18 years and older Exclusion Criteria: * History of macrolide allergy * Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin * Children less than 18 years of age * If a menstruating female, not pregnant and on adequate birth control

Locations (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Outcomes

Primary Outcomes

Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures

neg culture x3( sputum conversion)

Time frame: 6 months

Secondary Outcomes

Microbiological cultures

neg culture for 1 yr on treatment

Time frame: 1yr

Data from ClinicalTrials.gov

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