Cystic FibrosisPREDICTNCT02073409
PREDICT Trial: PRospective Evaluation of NTM Disease In CysTic Fibrosis
An observational study of Cystic Fibrosis, run by National Jewish Health at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 200 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2013to Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.
Who may be able to join
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
- Enrolled in the CFF Patient Registry (CFF PR)
- Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
- Male or female participant ≥ 6 years of age at enrollment
- Diagnosis of CF consistent with the 2017 CFF Guidelines
- NTM positive for a species or sub-species in the 2 years prior to enrollment that has never been treated.
- Willing to discontinue chronic azithromycin use for the duration of the study
Who cannot join
- Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the patient is being considered for this study
- History of solid organ or hematological transplantation
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
CFF Pediatric Program University of Michigan
Ann Arbor, Michigan, 48109
Children's Hospital Colorado
Aurora, Colorado, 80045
CFF Adult Program, Johns Hopkins University
Baltimore, Maryland, 21205
CFF Pediatric Program, University of Alabama
Birmingham, Alabama, 35233
Boston Children's Hospital, Brigham & Women's Hospital
Boston, Massachusetts
University of Vermont Medical Center
Burlington, Vermont
CFF Adult Program, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27517
Northwestern University
Chicago, Illinois
Nationwide Children's Hospital
Columbus, Ohio
CFF Adult Program, The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8558
National Jewish Health
Denver, Colorado, 80206
University of Florida
Gainesville, Florida
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire
Children's Hospital of Los Angeles
Los Angeles, California
CFF Pediatric Program, Columbia University
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
University of California San Diego
San Diego, California
CFF Pediatric Program Seattle Children's Hospital
Seattle, Washington, 98105
CFF Adult Program, University of Washington
Seattle, Washington, 98195
About this study
Official title: 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 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.
- Conditions
- Cystic Fibrosis
- Keywords
- Nontuberculous Mycobacteria
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CF patients | Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion meeting the diagnosis of NTM disease
Measured: 12 months intervals following study enrollment
Secondary outcomes (5)
Adherence to PREDICT protocol: number of respiratory cultures obtained per participant per year, withdrawals and major deviations from protocol
Measured: 12 months intervals following study enrollment
Incidence and prevalence of NTM species/subspecies by geographical region
Measured: 12 months intervals following study enrollment
Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site
Measured: 12 months intervals following study enrollment
Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE
Measured: 12 months intervals following study enrollment
Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R)
Measured: 12 months intervals following study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Children's Hospital Colorado
- Responsible party
- Principal investigator, Jerry A. Nick, M.D., National Jewish Health
- Investigators
- Jerry A Nick, MD, Principal investigator, National Jewish HealthStacey Martiniano, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073409
- Sponsor's protocol ID
- NTM-OB-17 (PREDICT PART A)
- Acronym
- PREDICT
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2014
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martiniano SL, Caceres SM, Poch K, Rysavy NM, Lovell VK, Armantrout E, Jones M, Anthony M, Keck A, Nichols DP, Vandalfsen JM, Sagel SD, Wagner B, Xie J, Weaver K, Heltshe SL, Daley CL, Davidson RM, Nick JA; Investigators of the Cystic Fibrosis NTM Consortium. Prospective evaluation of nontuberculous mycobacteria disease in cystic fibrosis: The design of the PREDICT study. J Cyst Fibros. 2024 Jan;23(1):50-57. doi: 10.1016/j.jcf.2023.08.007. Epub 2023 Sep 4.
PubMed 37666709
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Standardized Approach to Diagnosis (PREDICT) and Treatment (PATIENCE) of Nontuberculous Mycobacteria Disease in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02073409
- Acronym / sponsor ID
- PREDICT / NTM-OB-17 (PREDICT PART A)
- Conditions
- Cystic Fibrosis
- Keywords
- Nontuberculous Mycobacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation, Children's Hospital Colorado
- Study start
- Dec 2013
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF patients | – | –Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM. |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female subjects with CF age 6 years and older who have a positive sputum culture for NTM.
Key inclusion criteria (7 listed)
- Written informed consent (and assent when applicable) obtained from participant or participant's legal representative
- Enrolled in the CFF Patient Registry (CFF PR)
- Be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements
- Male or female participant ≥ 6 years of age at enrollment
- Diagnosis of CF consistent with the 2017 CFF Guidelines
Key exclusion criteria (3 listed)
- Prior or ongoing antibiotic treatment of the same NTM species or sub-species for which the patient is being considered for this study
- History of solid organ or hematological transplantation
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion meeting the diagnosis of NTM disease
Time frame: 12 months intervals following study enrollment
5 secondary outcomes
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
Incidence and prevalence of NTM species/subspecies by geographical region
Time frame: 12 months intervals following study enrollment
Proportion of eligible NTM positive individuals with CF enrolling in PREDICT by site
Time frame: 12 months intervals following study enrollment
Proportion of PREDICT participants with NTM disease diagnosis who enroll in Part B PATIENCE
Time frame: 12 months intervals following study enrollment
Clinical parameters and outcomes (FEV1, growth parameters, CFQ-R)
Time frame: 12 months intervals following study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Derived from this study: PubMed 37666709Martiniano SL, Caceres SM, Poch K, Rysavy NM, Lovell VK, Armantrout E, Jones M, Anthony M, Keck A, Nichols DP, Vandalfsen JM, Sagel SD, Wagner B, Xie J, Weaver K, Heltshe SL, Daley CL, Davidson RM, Nick JA; Investigators of the Cystic Fibrosis NTM Consortium. Prospective evaluation of nontuberculous mycobacteria disease in cystic fibrosis: The design of the PREDICT study. J Cyst Fibros. 2024 Jan;23(1):50-57. doi: 10.1016/j.jcf.2023.08.007. Epub 2023 Sep 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry A Nick, MD principal investigator
National Jewish Health
Stacey Martiniano, MD principal investigator
Children's Hospital Colorado
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by National Jewish Health at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion meeting the diagnosis of NTM disease (time frame: 12 months intervals following study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02073409, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.