PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis

NCT ID: NCT02419989

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2025-03-31

Brief Summary

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Isolation of nontuberculous mycobacteria (NTM) from the sputum of individuals with CF is an increasingly common finding, and the lack of an evidenced-based approach to treatment of NTM disease has been identified as one of the greatest unmet needs within the CF community. Current evidence predicts that the prevalence of NTM will remain relatively high in the CF population. Approaches to NTM disease treatment differ widely between centers, and expected outcomes are not known. This study is observational and follows current best practices. The study will help define response to treatment, and collect relevant data associated with treatment of NTM disease to build a framework for future therapeutic trials.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CF patients

Male and female subjects with CF age 6 years and older who meet diagnostic criteria for NTM disease through participation in the PREDICT (Part A) study who are being offered NTM treatment.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Previous participation in PREDICT and diagnosis of NTM disease for the same species of NTM
2. Intention to treat for NTM disease for M. avium complex or M. abscessus complex
3. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
4. Signed informed consent to participate in data submission to the CFF Patient Registry
5. Be willing and able to initiate treatment for NTM and to adhere to study procedures in the context of clinical care, and other protocol requirements

Exclusion Criteria

1. Pregnant or breastfeeding
2. Has any other condition that, in the opinion of the Site Investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Minimum Eligible Age

6 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Children's Hospital Colorado

OTHER

Sponsor Role collaborator

National Jewish Health

OTHER

Sponsor Role lead

Responsible Party

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Jerry A. Nick, M.D.

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerry A Nick, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Stacey Martiniano, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

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CFF Pediatric Program, University of Alabama

Birmingham, Alabama, United States

Site Status

Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status

University of California San Diego

San Diego, California, United States

Site Status

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

CFF Adult Program, Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Boston Children's Hospital, Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

CFF Pediatric Program University of Michigan

Ann Arbor, Michigan, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

CFF Pediatric Program, Columbia University

New York, New York, United States

Site Status

CFF Adult Program, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

CFF Pediatric Program Seattle Children's Hospital

Seattle, Washington, United States

Site Status

CFF Adult Program, University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NTM-OB-17 (PATIENCE PART B)

Identifier Type: -

Identifier Source: org_study_id

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