Registry Study of Systemic Antifungal Therapy in Adult Subjects with Invasive Mucormycosis or Invasive Aspergillosis Caused by a Non-fumigatus Species
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
- Scottsdale/Phoenix, Arizona: 17-004928
Sponsor Protocol Number: 9766-CL-0111
About this study
The purpose of this study is to obtain and report outcome data for adult subjects who received systemic antifungal therapy (AFT) for the treatment of invasive mucormycosis (IM) or invasive aspergillosis (IA) caused by a non-fumigatus species.
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:
- Subject has proven or probable IM or IA caused by a non-fumigatus species per EORTC/MSG criteria. Subjects with multiple fungal pathogens are eligible (i.e., niger/fumigatus, Rhizopus/Absidia).
- Subject is 18 years of age at the time they began treatment with a systemic AFT for their IFI.
- Subject has received or is receiving treatment with a systemic AFT active against IM or IA caused by a non-fumigatus species.
- Subject initiated systemic AFT for treatment of IM or IA caused by a non-fumigatus species in January 2016 or later.
- Subject 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.
- Subject who has completed therapy prior to registration must have day 42 vital status data available.
Exclusion Criteria:
- Subject only underwent surgery for the treatment of IM or IA caused by a non-fumigatus species (i.e., subject did not receive systemic antifungal treatment).
- Subject previously provided data for this registry.
- Subject who received an investigational drug used to treat an IFI within 30 days of starting treatment with an approved antifungal for their IFI.
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 |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Robert Orenstein, D.O. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available