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

Mycobacterium Avium Complex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600769
• Other study ID #: 263
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2008
• Last updated: May 19, 2017
• Start date: January 1991
• Est. completion date: May 18, 2017

Study information

• Verified date: May 2017
• Source: The University of Texas Health Science Center at Tyler
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 18, 2017
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mycobacterium Avium Complex
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections
• Nontuberculous Mycobacteria

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at Tyler	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures	neg culture x3( sputum conversion)	6 months
Secondary	Microbiological cultures	neg culture for 1 yr on treatment	1yr