Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:February 22, 2019
End Date:February 28, 2023
Contact:Andie Hendrick
Email:hendrmic@ohsu.edu
Phone:503-494-2136

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NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated
patients frequently experience debilitating side effects, and many patients delay the start
of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and
fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and
hematologic toxicity. To date, most of the evidence underlying the current treatment
recommendations has come from observational studies in which either a macrolide has been
combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The
proposed study will answer whether a third drug is necessary or whether taking two drugs can
increase tolerability without a substantial loss of efficacy.

Mycobacterium avium complex (MAC) are a subset of nontuberculous mycobacteria (NTM),
environmental bacteria that can cause chronic, debilitating pulmonary disease, primarily
affecting those over age 60. The goals of treatment are to improve symptoms, stop disease
progression, and clear the infection. We propose to address a longstanding controversy in the
therapy of pulmonary MAC disease, whether patients must take three antibiotics concomitantly,
or if two are sufficient. The study is a multicenter randomized pragmatic clinical trial to
compare azithromycin + ethambutol (2-drug therapy) vs. azithromycin + ethambutol + rifampin
(3-drug therapy) for non-cavitary pulmonary MAC disease. All clinical outcomes will be
considered standard of care and abstracted from clinical records. Therapy changes and adverse
events will be recorded at routine visits. Health-related quality of life (HRQoL) and
self-reported toxicity will be captured centrally in a web-based database, and CT scans will
be read centrally. Co-primary outcomes are culture conversion and tolerability of treatment.
The primary analysis for culture conversion will be conducted as a per-protocol
non-inferiority analysis, and the primary analysis for tolerability will be conducted as an
intention-to-treat superiority analysis.

Inclusion Criteria:

- Culture positive pulmonary MAC meeting ATS/IDSA disease criteria

- Age over 18 years

- Ability to provide informed consent

Exclusion Criteria:

- Fibrocavitary disease

- Planned surgery for MAC disease

- Prior multi-drug therapy for pulmonary NTM

- Cystic fibrosis

- HIV

- History of solid organ or hematologic transplant

- Significant drug-drug interaction not clinically manageable in the opinion of the
investigator

- Contraindication to any component of the study treatment regimen
We found this trial at
26
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Keira Cohen, MD
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Colin Swenson, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Pamela McShane, MD
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Douglas Hornick, MD
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Miami, Florida 33124
(305) 284-2211
Principal Investigator: Mehdi Mirsaeidi, MD, MPH
University of Miami A private research university with more than 15,000 students from around the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Kevin Winthrop, MD, MPH
Phone: 503-494-2136
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: David Horne, MD, MPH
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Peader Noone, MD
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Patrick Flume, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Charles L Daley, MD
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Kansas City, Kansas
Principal Investigator: Matthias Salathe, MD
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New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Charles Dela Cruz, MD, PhD
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Orleans, Louisiana 70112
Principal Investigator: Juzar Ali, MD
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70 Washington Square S
New York, New York 10012
(212) 998-1212
Principal Investigator: Doreen Addrizzo-Harris, MD
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Angela Domingo, MD
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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445 E 69th St
New York, New York 10021
(212) 746-1067
Principal Investigator: Meredith Turetz, MD
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Principal Investigator: Daniel Salerno, MD, MS
Temple University Temple University is many things to many people. A place to pursue life's...
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Rochester, Minnesota 55905
Principal Investigator: Timothy Aksamit, MD
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San Antonio, Texas 78229
Principal Investigator: Marcos Restrepo, MD, PhD
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San Diego, California 92093
Principal Investigator: Wael ElMaraachli, MD
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San Francisco, California 94143
Principal Investigator: Payam Nahid, MD, MPH
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450 Serra Mall
Stanford, California 94305
Principal Investigator: Steven Ruoss, MD
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Toronto, Ontario
Principal Investigator: Theodore Marras, MD
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Tyler, Texas 75708
Principal Investigator: David E Griffith, MD
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Vancouver, Washington 98664
Principal Investigator: Nicholas Wysham, MD
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Principal Investigator: Anne O'Donnell, MD
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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