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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Nontuberculous Mycobacteria; Mycobacterium Avium Complex

Treatments: Drug: Clarithromycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00600769

263

Details and patient eligibility

About

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

Full description

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

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

treatment of MAC and other NTM

Other group

Description:

Clarithromycin drug given twice daily.

Treatment:

Drug: Clarithromycin