PATIENCE Trial: Prospective Algorithm for Treatment of NTM in Cystic Fibrosis (PATIENCE)
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ClinicalTrials.gov Identifier: NCT02419989 |
Recruitment Status :
Recruiting
First Posted : April 17, 2015
Last Update Posted : May 13, 2021
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Condition or disease |
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Cystic Fibrosis |
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 |

Group/Cohort |
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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.
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- 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 ]
- Duration and combinations of NTM treatment regimens received [ Time Frame: At end of treatment interval ]
- 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 ]
- Proportion who complete ≥ 12 months of treatment since first negative culture [ Time Frame: At end of treatment interval ]
- Proportion eradicating NTM defined by ≥ 12 months of negative cultures since end of treatment [ Time Frame: 12 months following end of treatment ]
- Variability between sites for NTM eradication success [ Time Frame: 12 months following end of treatment ]
- Time to treatment discontinuation due to treatment success [ Time Frame: 12 months following end of treatment ]
- Clinical outcomes (FEV1, growth parameters, CFQ-R) [ Time Frame: 12 months following end of treatment ]
Biospecimen Retention: Samples With DNA

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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 |
Inclusion Criteria:
- Previous participation in PREDICT and diagnosis of NTM disease for the same species of NTM
- Intention to treat for NTM disease for M. avium complex or M. abscessus complex
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
- Signed informed consent to participate in data submission to the CFF Patient Registry
- 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:
- Pregnant or breastfeeding
- 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

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

Principal Investigator: | Jerry A Nick, MD | National Jewish Health | |
Principal Investigator: | Stacey Martiniano, MD | Children's Hospital Colorado |
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: | May 13, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Nontuberculous Mycobacteria |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |