A Non-Interventional Registry Study of Systemic Antifungal Therapy in Adult Subjects with Invasive Mucormycosis or Invasive Aspergillosis Caused by a Non-fumigatus Species
The objective of this study is to obtain and report outcome data for adult patients who received systemic antifungal therapy (AFT) for the treatment of invasive mucormycosis (IM) or invasive aspergillosis (IA) caused by a non-fumigatus species.
Study phase: IV
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
1. Patient has proven or probable IM or IA caused by a non-fumigatus species. Patients with multiple fungal pathogens are eligible (i.e., niger/fumigatus, Rhizopus/Absidia).
2. Patient is 18 years of age at the time they began treatment with a systemic AFT for their IFI.
3. Patient has received or is receiving treatment with a systemic AFT active against IM or IA caused by a non-fumigatus species.
4. Patient initiated systemic AFT for treatment of IM or IA caused by a non-fumigatus species in January 2016 or later.
5. Patient or legal representative has provided the appropriate consent and release to access medical records.
6. Patient who has completed therapy prior to registration must have day 42 vital status data available.
1. Patient only underwent surgery for the treatment of IM or IA caused by a non-fumigatus species (i.e., patient did not receive systemic antifungal treatment).
2. Patient previously provided data for this registry.
3. Patient who received an investigational drug used to treat an IFI within 30 days of starting treatment with an approved antifungal for their IFI.
Primary disease category: HIV/AIDS & Infectious Disease
Sponsor: Astellas Pharma Global Development, Inc.
Projected enrollment dates: January 2017 to January 2023
Official study title: A Non-Interventional Registry Study of Systemic Antifungal Therapy in Adult Subjects with Invasive Mucormycosis or Invasive Aspergillosis Caused by a Non-fumigatus Species