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

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

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

Study Overview

• Status: Completed
• Conditions: Mycobacterium Avium Complex Lung Disease
• Intervention / Treatment: Drug: clarithromycin, rifabutin

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: clarithromycin and rifabutin/rifampin; Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.	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.; Other Names: Biaxin, mycobutin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	sputum conversion culture neg x3	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and microbiological outcomes	culture neg 1 yr on treatment	1 yr

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at Tyler
• Collaborators: Pfizer; Abbott

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 1995
• Primary Completion (ACTUAL): August 7, 2002
• Study Completion (ACTUAL): May 18, 2017

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 11, 2008
• First Posted (ESTIMATE): January 23, 2008

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: MAC
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Mycobacterium Infections, Nontuberculous; Lung Diseases; Mycobacterium avium-intracellulare Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antitubercular Agents; Antibiotics, Antitubercular; Rifabutin; Clarithromycin
• Other Study ID Numbers: 447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share.