Registry of Patients Treated With Systemic Mold-Active Triazoles
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-001351
NCT ID: NCT03066011
Sponsor Protocol Number: 9766-MA-3034
About this study
The purpose of this study is to describe representative real-world patterns of care for the management of invasive fungal infections (IFIs), including invasive mold infection (IMI). Specifically, the study goals are to examine real world patient characteristics and treatment patterns, associated healthcare resource utilization, and outcomes associated with use of mold-active triazoles (MATs) to treat invasive fungal infections (IFIs).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
For enrollment, patients must meet both of the following inclusion criteria:
- Taking one of the following target drugs at the time of enrollment: ISAV, VORI, POSA.
- For patients ≥ 18 years old, patient or legal representative has provided the appropriate consent and/or release, consistent with local requirements, to access medical records given consent and/or data release if required by institutional policy, state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of this data. For patients < 18 years old, informed consent must be obtained from the patient’s parent(s) or legal guardian(s) and patient assent (where appropriate) must be given.
Exclusion Criteria:
Patients meeting any of the following criteria must be excluded:
- Currently enrolled in any clinical trial with an investigational antifungal agent. Individuals who subsequently enroll in an investigational antifungal study will be discontinued and data collected up to the time of investigational product will be evaluable.
- Patients who died before entering the study.
- Patients who previously participated in this registry.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jason Barreto, Pharm.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available