Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

Mycobacterium Avium Complex Lung Disease Clinical Trial

Official title:

Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598897
• Other study ID #: 447
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2008
• Last updated: May 19, 2017
• Start date: August 1995
• 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

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Description:

Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: May 18, 2017
• Est. primary completion date: August 7, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet American Thoracic Society criteria for nontuberculous mycobacterial 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 mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).

• Adults age 18 and older

• Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

• History of allergy to study drugs

• If a mensruating female, not pregnant and on adequate birth control.

• Children less than 18 years of age

• HIV + or at high risk for HIV infection.

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium Avium Complex Lung Disease
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• clarithromycin, rifabutin
Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.

Locations

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

Sponsors (3)

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

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	sputum conversion culture neg x3	6 months
Secondary	Clinical and microbiological outcomes	culture neg 1 yr on treatment	1 yr