A Registry of Antifungal Therapy in Adults with Either Invasive Mucormycosis or Invasive Aspergillosis
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: 17-001278
Sponsor Protocol Number: 17-001278
About this study
The objective 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
- Proven or probable IM or IA caused by a non-fumigatus species per EORTC/MSG criteria
- Multiple fungal pathogens are eligible (i.e., niger/fumigatus, Rhizopus/Absidia)
- Age 18 years at time began treatment with a systemic AFT for their IFI
- Has received or is receiving treatment with a systemic AFT active against IM or IA caused by a non-fumigatus species
- 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 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
- Has completed therapy prior to registration must have day 42 vital status data available
Exclusion Criteria
- Only underwent surgery for the treatment of IM or IA caused by a non-fumigatus species (i.e. did not receive systemic antifungal treatment)
- Previously provided data for this registry
- 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Jason Barreto, Pharm.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available