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Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease (MAC2v3)

Primary Purpose

Mycobacterium Avium Complex, Nontuberculous Mycobacterium Infection

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Azithromycin
Ethambutol
Rifampin
Sponsored by
Kevin Winthrop
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium Complex focused on measuring NTM, MAC, mycobacteria, nontuberculous mycobacteria, azithromycin, ethambutol, rifampin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Patients who have cumulatively taken 6 weeks or more of multi-drug antimicrobial treatment for MAC
  • Patients who are currently taking or have taken multi-drug antimicrobial treatment for NTM within the prior 30 days
  • Diagnosis of Cystic fibrosis
  • Diagnosis of 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

Sites / Locations

  • Loma Linda University Medical CenterRecruiting
  • University of California, San DiegoRecruiting
  • University of California, San FranciscoRecruiting
  • Stanford UniversityRecruiting
  • National Jewish HealthRecruiting
  • Yale University
  • Georgetown University
  • University of Miami
  • Tampa VA Medical CenterRecruiting
  • Emory UniversityRecruiting
  • Kaiser Permanente HawaiiRecruiting
  • University of IowaRecruiting
  • University of Kansas
  • Louisina State UniversityRecruiting
  • Johns Hopkins UniversityRecruiting
  • Mayo ClinicRecruiting
  • Northwell HealthRecruiting
  • New York UniversityRecruiting
  • Columbia University Medical CenterRecruiting
  • University of North CarolinaRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Temple UniversityRecruiting
  • Medical University of South CarolinaRecruiting
  • University of Texas Health Science CenterRecruiting
  • University of Washington
  • Vancouver ClinicRecruiting
  • University of Wisconsin School of Medicine and Public HealthRecruiting
  • University Health NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2-drug regimen

3-drug regimen

Arm Description

This arm is a 3 time per week (TIW) treatment regimen that includes azithromycin 500 mg po + ethambutol 25 mg/kg Treatment changes are at the discretion of the treating physician and patient. Where possible, changes in dosing or frequency that allow the patient to continue taking the assigned drugs during the 12 months study period are preferred.

This arm is a 3 time per week (TIW) treatment regimen that includes azithromycin 500 mg po + ethambutol 25 mg/kg + rifampin 600 mg Treatment changes are at the discretion of the treating physician and patient. Where possible, changes in dosing or frequency that allow the patient to continue taking the assigned drugs during the 12 months study period are preferred.

Outcomes

Primary Outcome Measures

Acid-fast bacilli (AFB) culture negativity
Two consecutive negative AFB cultures by 12 months post randomization without reversion to positive
Therapy completion
The proportion of patients who complete 12 months of therapy on their assigned regimen with "satisfactory adherence". "Satisfactory adherence" is defined as taking 80% of their prescribed doses/not missing more than 75 days of treatment.

Secondary Outcome Measures

QOL-B Respiratory Symptoms Score
Quality of Life-Bronchiectasis (QOL-B) with NTM module The QOL-B is a self-administered questionnaire that has been validated in patients with bronchiectasis. The questionnaire measures 8 separate domains: Physical Functioning, Role Functioning, Vitality, Emotional Functioning, Social Functioning, Treatment Burden, Health Perceptions, and Respiratory Symptoms.
NTM Symptoms Score
Quality of Life-Bronchiectasis (QOL-B) with NTM module The QOL-B is a self-administered questionnaire that has been validated in patients with bronchiectasis. The NTM module includes 4 additional domains: Eating Problems, Body Image, Digestive Symptoms, and NTM Symptoms. No total score is calculated.
PROMIS Fatigue 7a short form score
PROMIS Fatigue 7a short form score The PROMIS Fatigue item banks assess a range of self-reported symptoms over the past seven days, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Each question has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. The lowest possible raw score (indicating the highest subjective level of fatigue) is 7; and the highest possible raw score (indicating the lowest subjective level of fatigue) is 35.
Fatigue AE proportion
Self-report, Moderate or worse
Gastrointestinal AE proportion
Self-report, Moderate or worse: Nausea, diarrhea, decreased appetite, OR abdominal pain
Liver AE proportion
Laboratory grade 2 or higher abnormality
Macrolide resistance
Susceptibility at last positive culture

Full Information

First Posted
September 11, 2018
Last Updated
September 26, 2023
Sponsor
Kevin Winthrop
Collaborators
Patient-Centered Outcomes Research Institute, National Jewish Health, The University of Texas Health Science Center at Tyler, University Health Network, Toronto, New York University, Medical University of South Carolina, Mayo Clinic, Louisiana State University Health Sciences Center in New Orleans, University of California, San Diego, Stanford University, University of Kansas, Vancouver Clinic, University of California, San Francisco, University of Washington, Johns Hopkins University, University of Miami, Emory University, University of Iowa, University of North Carolina, Temple University, Loma Linda University, Columbia University, University of Wisconsin, Madison, Northwell Health, Kaiser Permanente Hawaii, James A. Haley Veterans Administration Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03672630
Brief Title
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
Acronym
MAC2v3
Official Title
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kevin Winthrop
Collaborators
Patient-Centered Outcomes Research Institute, National Jewish Health, The University of Texas Health Science Center at Tyler, University Health Network, Toronto, New York University, Medical University of South Carolina, Mayo Clinic, Louisiana State University Health Sciences Center in New Orleans, University of California, San Diego, Stanford University, University of Kansas, Vancouver Clinic, University of California, San Francisco, University of Washington, Johns Hopkins University, University of Miami, Emory University, University of Iowa, University of North Carolina, Temple University, Loma Linda University, Columbia University, University of Wisconsin, Madison, Northwell Health, Kaiser Permanente Hawaii, James A. Haley Veterans Administration Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Avium Complex, Nontuberculous Mycobacterium Infection
Keywords
NTM, MAC, mycobacteria, nontuberculous mycobacteria, azithromycin, ethambutol, rifampin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2-drug regimen
Arm Type
Active Comparator
Arm Description
This arm is a 3 time per week (TIW) treatment regimen that includes azithromycin 500 mg po + ethambutol 25 mg/kg Treatment changes are at the discretion of the treating physician and patient. Where possible, changes in dosing or frequency that allow the patient to continue taking the assigned drugs during the 12 months study period are preferred.
Arm Title
3-drug regimen
Arm Type
Active Comparator
Arm Description
This arm is a 3 time per week (TIW) treatment regimen that includes azithromycin 500 mg po + ethambutol 25 mg/kg + rifampin 600 mg Treatment changes are at the discretion of the treating physician and patient. Where possible, changes in dosing or frequency that allow the patient to continue taking the assigned drugs during the 12 months study period are preferred.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Intervention Description
Azithromycin 500 MG Oral Tablet [ZITHROMAX]
Intervention Type
Drug
Intervention Name(s)
Ethambutol
Other Intervention Name(s)
Myambutol
Intervention Description
Ethambutol 25 mg/kg [MYAMBUTOL]
Intervention Type
Drug
Intervention Name(s)
Rifampin
Other Intervention Name(s)
Rifadin
Intervention Description
Rifampin 600 MG [RIFADIN]
Primary Outcome Measure Information:
Title
Acid-fast bacilli (AFB) culture negativity
Description
Two consecutive negative AFB cultures by 12 months post randomization without reversion to positive
Time Frame
12 months post randomization
Title
Therapy completion
Description
The proportion of patients who complete 12 months of therapy on their assigned regimen with "satisfactory adherence". "Satisfactory adherence" is defined as taking 80% of their prescribed doses/not missing more than 75 days of treatment.
Time Frame
12 months post randomization
Secondary Outcome Measure Information:
Title
QOL-B Respiratory Symptoms Score
Description
Quality of Life-Bronchiectasis (QOL-B) with NTM module The QOL-B is a self-administered questionnaire that has been validated in patients with bronchiectasis. The questionnaire measures 8 separate domains: Physical Functioning, Role Functioning, Vitality, Emotional Functioning, Social Functioning, Treatment Burden, Health Perceptions, and Respiratory Symptoms.
Time Frame
12 months post randomization
Title
NTM Symptoms Score
Description
Quality of Life-Bronchiectasis (QOL-B) with NTM module The QOL-B is a self-administered questionnaire that has been validated in patients with bronchiectasis. The NTM module includes 4 additional domains: Eating Problems, Body Image, Digestive Symptoms, and NTM Symptoms. No total score is calculated.
Time Frame
12 months post randomization
Title
PROMIS Fatigue 7a short form score
Description
PROMIS Fatigue 7a short form score The PROMIS Fatigue item banks assess a range of self-reported symptoms over the past seven days, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. Each question has five response options ranging in value from one to five. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. The lowest possible raw score (indicating the highest subjective level of fatigue) is 7; and the highest possible raw score (indicating the lowest subjective level of fatigue) is 35.
Time Frame
12 months post randomization
Title
Fatigue AE proportion
Description
Self-report, Moderate or worse
Time Frame
Cumulative to 12 months
Title
Gastrointestinal AE proportion
Description
Self-report, Moderate or worse: Nausea, diarrhea, decreased appetite, OR abdominal pain
Time Frame
up to 12 months
Title
Liver AE proportion
Description
Laboratory grade 2 or higher abnormality
Time Frame
up to 12 months
Title
Macrolide resistance
Description
Susceptibility at last positive culture
Time Frame
12 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Patients who have cumulatively taken 6 weeks or more of multi-drug antimicrobial treatment for MAC Patients who are currently taking or have taken multi-drug antimicrobial treatment for NTM within the prior 30 days Diagnosis of Cystic fibrosis Diagnosis of 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Miller
Phone
503-346-1548
Email
millehal@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Bouchat
Phone
503-494-2568
Email
johdanie@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Henkle, PhD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kevin L Winthrop, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dafne Moretta, MD
Ext
47745
Email
DMoretta@llu.edu
First Name & Middle Initial & Last Name & Degree
Dafne Moretta, MD
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy Zhang
Phone
619-471-0820
Email
jiz161@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Jenna Mielke
Phone
619-471-0822
Email
jmielke@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Wael ElMaraachli, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoshana Zha, MD, PhD
Email
Shoshana.Zha@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Sophia Sussman
Phone
415-218-7859
Email
Sophia.Sussman2@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Payam Nahid, MD, MPH
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan S. Jacobs, RN, MS
Phone
650-725-8083
Email
ssjpulm@stanford.edu
First Name & Middle Initial & Last Name & Degree
Steven Ruoss, MD
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrah Levin, MPH
Phone
303-398-1407
Email
levina@njhealth.org
First Name & Middle Initial & Last Name & Degree
Charles L Daley, MD
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Withdrawn
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Terminated
Facility Name
Tampa VA Medical Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Cruz
Phone
813-972-2000
Ext
6933
Email
Michelle.cruz@va.gov
First Name & Middle Initial & Last Name & Degree
Heather Bogle
Phone
813-972-2000
Ext
5293
Email
Heather.bogle@va.gov
First Name & Middle Initial & Last Name & Degree
Anthony Canella, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Cox
Phone
404-251-1705
Email
elizabeth.m.cox@emory.edu
First Name & Middle Initial & Last Name & Degree
Colin Swenson, MD
Facility Name
Kaiser Permanente Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kesh Morgan
Phone
808-432-8235
Email
kesha.t.morgan@kp.org
First Name & Middle Initial & Last Name & Degree
Janet Myers, MD
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet Keating
Phone
319-356-3241
Email
Janet-keating@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Douglas Hornick, MD
Facility Name
University of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Terminated
Facility Name
Louisina State University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Lapinel, MD
Phone
504-568-2706
Email
nlapin@lsuhsc.edu
First Name & Middle Initial & Last Name & Degree
Juzar Ali, MD
First Name & Middle Initial & Last Name & Degree
Nicole Lapinel, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Nguyen, MS
Phone
443-287-6283
Email
j.nguyen@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Elisa Ignatius, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Hammel, MA
Phone
507-293-3316
Email
hammel.laura@mayo.edu
First Name & Middle Initial & Last Name & Degree
Timothy Aksamit, MD
Facility Name
Northwell Health
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Hayes, MD
Email
lhayes@northwell.edu
First Name & Middle Initial & Last Name & Degree
Marcia Epstein, MD
Phone
516-562-4280
Email
MEpstein@northwell.edu
First Name & Middle Initial & Last Name & Degree
Lisa Hayes, MD
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Lau
Phone
646-754-4679
Email
Stephanie.Lau@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Doreen Addrizzo-Harris, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela DiMango, MD
Phone
212-305-5730
First Name & Middle Initial & Last Name & Degree
Angela Dimango, MD
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Pettee
Phone
919-843-4450
Email
jackson_pettee@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Daniels Leigh Anne, MD, MPH
First Name & Middle Initial & Last Name & Degree
Kenneth Olivier, MD, MPH
First Name & Middle Initial & Last Name & Degree
Kunal Jakharia, MD
First Name & Middle Initial & Last Name & Degree
Kunal Patel, MD, PhD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Miller
Phone
503-346-1548
Email
millehal@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kevin Winthrop, MD, MPH
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Salerno, MD, MS
Phone
215-707-1359
Email
breathe@temple.edu
First Name & Middle Initial & Last Name & Degree
Daniel Salerno, MD, MS
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abbey Grady, MPH
Phone
843-792-2072
Email
gradyabi@musc.edu
First Name & Middle Initial & Last Name & Degree
Patrick Flume, MD
Facility Name
University of Texas Health Science Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebekah Hibbard, BS
Phone
903-877-8246
Email
rebekah.hibbard@uthct.edu
First Name & Middle Initial & Last Name & Degree
Julie V Philley, MD
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Vancouver Clinic
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mattison Martin, BS
Phone
360-397-3388
Email
research@tvc.org
First Name & Middle Initial & Last Name & Degree
Nicholas Wysham, MD
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Saddler, MD
First Name & Middle Initial & Last Name & Degree
Chris Saddler, MD
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matty Mehrabi
Phone
416-603-5726
Email
Matty.Mehrabi@uhn.ca
First Name & Middle Initial & Last Name & Degree
Theodore Marras, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A Full Data Package will be made available in a PCORI-designated repository. The Full Data Package includes the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code from the PCORI-funded research project. The Analyzable Dataset includes a final cleaned and locked data set that contains all the data used in conducting the analyses reported in the PCORI Final Research Report and is de-identified in accordance with the HIPAA Privacy Rule (45 C.F.R. § 164.514(b)).
IPD Sharing Time Frame
The dataset will be available after completion of the study and publication of results.
IPD Sharing Access Criteria
Third party data requests will be reviewed by a committee, and approved requests will require a DUA.
Citations:
PubMed Identifier
25692495
Citation
Henkle E, Hedberg K, Schafer S, Novosad S, Winthrop KL. Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012. Ann Am Thorac Soc. 2015 May;12(5):642-7. doi: 10.1513/AnnalsATS.201412-559OC.
Results Reference
background
PubMed Identifier
20538958
Citation
Prevots DR, Shaw PA, Strickland D, Jackson LA, Raebel MA, Blosky MA, Montes de Oca R, Shea YR, Seitz AE, Holland SM, Olivier KN. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med. 2010 Oct 1;182(7):970-6. doi: 10.1164/rccm.201002-0310OC. Epub 2010 Jun 10.
Results Reference
background
PubMed Identifier
20508209
Citation
Winthrop KL, McNelley E, Kendall B, Marshall-Olson A, Morris C, Cassidy M, Saulson A, Hedberg K. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med. 2010 Oct 1;182(7):977-82. doi: 10.1164/rccm.201003-0503OC. Epub 2010 May 27.
Results Reference
background
PubMed Identifier
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Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

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