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

This study is ongoing, but not recruiting participants.

First Received: January 14, 2008 No Changes Posted

Sponsors and Collaborators:	The University of Texas Health Science Center at Tyler Abbott
Information provided by:	The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:	NCT00600769

Purpose

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

Condition	Intervention	Phase
Non-Tuberculous Mycobacteria Mycobacterium Avium Complex	Drug: Clarithromycin	Phase IV

Drug Information available for: Clarithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)

Further study details as provided by The University of Texas Health Science Center at Tyler:

Primary Outcome Measures:

Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at 3 months, then at 6 months, then annually, and prn for life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological cultures [ Time Frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at 3 months, then at 6 months, then annually, and prn for life ] [ Designated as safety issue: No ]

Enrollment:	210
Study Start Date:	January 1991
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: Clarithromycin Dosage dependent on clinical factors such as age, weight and patient-specific health status

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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; 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600769

Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center at Tyler

Abbott

More Information

No publications provided

Responsible Party:	The University of Texas Health Science Center at Tyler ( Richard J. Wallace Jr., M.D. )
Study ID Numbers:	263
Study First Received:	January 14, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00600769 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at Tyler:

MAC
NTM

Study placed in the following topic categories:

Bacterial Infections
Anti-Bacterial Agents
Clarithromycin
Gram-Positive Bacterial Infections

Mycobacterium Infections
Mycobacterium Avium Complex Infection
Mycobacterium Infections, Atypical
Mycobacterium avium-intracellulare Infection

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Actinomycetales Infections
Mycobacterium Infections, Atypical
Pharmacologic Actions

Mycobacterium avium-intracellulare Infection
Clarithromycin
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Therapeutic Uses
Mycobacterium Infections

ClinicalTrials.gov processed this record on May 06, 2009