PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - 99 |
| Updated: | 2/1/2018 |
| Start Date: | January 2014 |
| End Date: | March 2023 |
| Contact: | Marion Jones, RN |
| Email: | jonesm@njhealth.org |
| Phone: | (303) 398-1265 |
Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis
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.
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.
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
We found this trial at
10
sites
13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Stacey Martiniano, MD
Phone: 720-777-2945
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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1011 North University Avenue
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Principal Investigator: Lindsay Caverly, MD
Phone: 734-615-3266
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Baltimore, Maryland 21205
Principal Investigator: Keira Cohen, MD
Phone: 410-614-1409
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Birmingham, Alabama 35233
Principal Investigator: George M Solomon, MD
Phone: 205-638-9410
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Chapel Hill, North Carolina 27517
Principal Investigator: Jennifer Goralski, MD
Phone: 919-445-2855
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Dallas, Texas 75390
Principal Investigator: Raksha Jain, MD
Phone: 214-648-2817
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1400 Jackson St
Denver, Colorado 80206
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Jerry A Nick, MD
Phone: 303-270-2333
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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622 West 168th Street
New York, New York 10032
New York, New York 10032
Principal Investigator: Emily DiMango, MD
Phone: 215-305-4675
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4800 Sand Point Way Northeast
Seattle, Washington 98105
Seattle, Washington 98105
Principal Investigator: Ronald Gibson, MD
Phone: 206-987-3921
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Seattle, Washington 98195
Principal Investigator: Moira Aitken, MD
Phone: 206-543-7382
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