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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02419989
Recruitment Status : Recruiting
First Posted : April 17, 2015
Last Update Posted : October 5, 2020
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Children's Hospital Colorado
Information provided by (Responsible Party):
Jerry A. Nick, M.D., National Jewish Health

Study Description
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Brief Summary:
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.

Condition or disease
Cystic Fibrosis

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis
Actual Study Start Date : January 2014
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion who adhere to the protocol based on: number of respiratory cultures obtained per year, withdrawals or major deviations from protocol [ Time Frame: 12 months following end of antibiotic treatment ]

Secondary Outcome Measures :
  1. Duration and combinations of NTM treatment regimens received [ Time Frame: At end of treatment interval ]
  2. Proportion requiring antibiotic course change due to intolerance or lack of microbiological conversion (i.e. eradication from sputum) [ Time Frame: At end of treatment interval ]
  3. Proportion who complete ≥ 12 months of treatment since first negative culture [ Time Frame: At end of treatment interval ]
  4. Proportion eradicating NTM defined by ≥ 12 months of negative cultures since end of treatment [ Time Frame: 12 months following end of treatment ]
  5. Variability between sites for NTM eradication success [ Time Frame: 12 months following end of treatment ]
  6. Time to treatment discontinuation due to treatment success [ Time Frame: 12 months following end of treatment ]
  7. Clinical outcomes (FEV1, growth parameters, CFQ-R) [ Time Frame: 12 months following end of treatment ]

Biospecimen Retention:   Samples With DNA
Samples collected may include serum, sputum, whole blood, breath, urine, and NTM isolates.

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects with CF age 6 years and older with a confirmed diagnosis of NTM disease who are initiating treatment for NTM.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419989


Contacts
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Contact: Valerie Lovell, RN (303) 398-1265 lovellv@njhealth.org
Contact: Meg Anthony, MSW (720) 777-2945 Meg.Anthony@childrenscolorado.org

Locations
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United States, Alabama
CFF Pediatric Program, University of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Katie Brand    205-638-9410    kbrand@peds.uab.edu   
Principal Investigator: George M Solomon, MD         
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Meg Anthony, MSW    720-777-2945    Meg.Anthony@childrenscolorado.org   
Principal Investigator: Stacey Martiniano, MD         
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Sarah Ellington, RN    303-270-2333    ellingtons@njhealth.org   
Principal Investigator: Jerry A Nick, MD         
United States, Maryland
CFF Adult Program, Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21205
Contact: Mary Rykiel    410-614-1409    mrykiel1@jhmi.edu   
Principal Investigator: Keira Cohen, MD         
United States, Michigan
CFF Pediatric Program University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Dawn Kruse    734-615-3266    dmkruse@med.umich.edu   
Principal Investigator: Lindsay Caverly, MD         
United States, New York
CFF Pediatric Program, Columbia University Recruiting
New York, New York, United States, 10032
Contact: Amanda Kramer    215-305-4675    ARK2187@columbia.edu   
Principal Investigator: Emily DiMango, MD         
United States, North Carolina
CFF Adult Program, University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Kelsey Haywood    919-445-2855    kelsey_haywood@med.unc.edu   
Principal Investigator: Jennifer Goralski, MD         
United States, Texas
CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75390-8558
Contact: Ashley Keller    214-648-2817    Ashley.Keller@UTSouthwestern.edu   
Principal Investigator: Raksha Jain, MD         
United States, Washington
CFF Pediatric Program Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Sharon McNamara    206-987-3921    sharon.mcnamara@seattlechildrens.org   
Principal Investigator: Ronald Gibson, MD         
CFF Adult Program, University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Teresa Gambol    206-543-7382    TGambol@medicine.washington.edu   
Principal Investigator: Moira Aitken, MD         
Sponsors and Collaborators
National Jewish Health
Cystic Fibrosis Foundation
Children's Hospital Colorado
Investigators
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Principal Investigator: Jerry A Nick, MD National Jewish Health
Principal Investigator: Stacey Martiniano, MD Children's Hospital Colorado
More Information
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Responsible Party: Jerry A. Nick, M.D., Professor of Medicine, National Jewish Health
ClinicalTrials.gov Identifier: NCT02419989    
Other Study ID Numbers: NTM-OB-17 (PATIENCE PART B)
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jerry A. Nick, M.D., National Jewish Health:
Nontuberculous Mycobacteria
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases