Skip to main content
OpenTrials
Completed

NCT Number: NCT00600769

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nontuberculous Mycobacteria Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Avium Complex Mycobacterium Infections Mycobacterium Infections, Nontuberculous Mycobacterium avium-intracellulare Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clarithromycin

Drug

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

Other names: Biaxin

Primary outcomes

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

    Time frame: 6 months

    neg culture x3( sputum conversion)

Secondary outcomes

  1. Microbiological cultures

    Time frame: 1yr

    neg culture for 1 yr on treatment

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at Tyler

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
1991
Primary completion
2006
Study completion
2017
First posted
Jan 25, 2008
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.