PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis

Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02073409

Acronym

PREDICT

Enrollment

200

Registered

2014-02-27

Start date

2013-12-31

Completion date

2025-03-31

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Nontuberculous Mycobacteria

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 99 Years

Healthy volunteers

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 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

Design outcomes

Primary

Measure	Time frame
Proportion meeting the diagnosis of NTM disease	12 months intervals following study enrollment

Secondary

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

Countries

United States

Outcome results