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

Phase 4

Completed

• Conditions: Mycobacterium Avium Complex; Nontuberculous Mycobacteria
• Interventions: Drug: Clarithromycin

• Registration Number: NCT00600769
• Lead Sponsor: The University of Texas Health Science Center at Tyler

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 1991-01
• Primary Completion: 2006-11
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Status Verified: 2017-05
• Study Completion: 2017-05-18
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment of MAC and other NTM	Clarithromycin	Clarithromycin drug given twice daily.

Primary Outcome Measures

Name	Time	Method
Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures	6 months	neg culture x3( sputum conversion)

Secondary Outcome Measures

Name	Time	Method
Microbiological cultures	1yr	neg culture for 1 yr on treatment

Trial Locations

Locations (1)

The University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States