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PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis (PREDICT)

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ClinicalTrials.gov Identifier: NCT02073409
Recruitment Status : Recruiting
First Posted : February 27, 2014
Last Update Posted : May 13, 2021
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Children's Hospital Colorado
Information provided by (Responsible Party):
Jerry A. Nick, M.D., National Jewish Health

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 the diagnosis 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 diagnosis differ widely between centers. This study is observational and follows current best practices. The study will help standardize the diagnosis and collect relevant data associated with the diagnosis of NTM disease to build a framework for future therapeutic trials.

Condition or disease
Cystic Fibrosis

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Study Type : Observational
Estimated Enrollment : 200 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
Study Start Date : December 2013
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Group/Cohort
CF patients
Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.



Primary Outcome Measures :
  1. Proportion meeting the diagnosis of NTM disease [ Time Frame: 12 months intervals following study enrollment ]

Secondary Outcome Measures :
  1. Adherence to PREDICT protocol: number of respiratory cultures obtained per participant per year, withdrawals and major deviations from protocol [ Time Frame: 12 months intervals following study enrollment ]
  2. Incidence and prevalence of NTM species/subspecies by geographical region [ Time Frame: 12 months intervals following study enrollment ]
  3. Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site [ Time Frame: 12 months intervals following study enrollment ]
  4. Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE [ Time Frame: 12 months intervals following study enrollment ]
  5. Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R) [ Time Frame: 12 months intervals following study enrollment ]

Biospecimen Retention:   Samples Without DNA
Samples collected may include serum, sputum, whole blood, breath, urine, and NTM isolates.


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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 who have a positive sputum culture for NTM.
Criteria

Inclusion Criteria:

  1. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
  2. Enrolled in the CFF Patient Registry (CFF PR)
  3. Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
  4. Male or female participant ≥ 6 years of age at enrollment who are able to reliably expectorate sputum and/or willing to undergo sputum induction (if necessary)
  5. Diagnosis of CF consistent with the 2017 CFF Guidelines
  6. NTM positive for a species or sub-species in the 2 years prior to enrollment that has never been treated.
  7. Willing to discontinue chronic azithromycin use for the duration of the study

Exclusion Criteria:

  1. Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the patient is being considered for this study
  2. History of solid organ or hematological transplantation
  3. 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

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): NCT02073409


Contacts
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Contact: Valerie Lovell, RN (303) 398-1265 lovellv@njhealth.org
Contact: Jennifer Sanchez (720) 777-4949 jennifer.sanchez@childrenscolorado.org

Locations
Show Show 20 study locations
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
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Responsible Party: Jerry A. Nick, M.D., Professor of Medicine, National Jewish Health
ClinicalTrials.gov Identifier: NCT02073409    
Other Study ID Numbers: NTM-OB-17 (PREDICT PART A)
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021

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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