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

NCT00598897 | Completed Phase 4

• 1 other identifier: 447
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Mycobacterium Avium Complex Lung Disease

Keywords

MAC

Outcome Measures

Primary Outcomes (1)

• Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures

  sputum conversion culture neg x3

  6 months

Secondary Outcomes (1)

• Clinical and microbiological outcomes

  1 yr

Study Arms (1)

clarithromycin and rifabutin/rifampin

EXPERIMENTAL

Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.

Drug: clarithromycin, rifabutin

Interventions

clarithromycin, rifabutin DRUG

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.

Also known as: Biaxin, mycobutin

clarithromycin and rifabutin/rifampin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at Tyler: lead
• Abbott: collaborator
• Pfizer: collaborator

Study Sites (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75708, United States

Location

MeSH Terms

Interventions

Clarithromycin; Rifabutin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Richard J Wallace Jr., M.D.

  The University of Texas Health Science Center at Tyler

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman Department of Microbiology

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 23, 2008
• Study Start: August 1, 1995
• Primary Completion: August 7, 2002
• Study Completion: May 18, 2017
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)