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Liposomal Amphotericin B
Olorofim vs AmBisome® for Aspergillosis (OASIS Trial)
Phase 3
Recruiting
Led By Johan Maertens, MD
Research Sponsored by F2G Biotech GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with proven invasive aspergillosis (IA) at any site or probable lower respiratory tract disease (LRTD) IA per EORTC/MSG 2019 criteria as adapted for this study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at any time through end of treatment
Awards & highlights
OASIS Trial Summary
This trialcompares two treatments for a type of lung infection caused by Aspergillus species.
Who is the study for?
Adults over 18 years old, weighing more than 40 kg with proven or probable invasive aspergillosis (IA) who need non-azole antifungal therapy due to azole resistance, infection despite azole use, or potential drug interactions. Not for pregnant/breastfeeding women, those with chronic aspergillosis forms, other active fungal infections except certain candidiasis cases, hepatic dysfunction, known allergies to study drugs, suspected mucormycosis, echinocandin-treated Candida prophylaxis patients or untreated HIV.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a new antifungal treatment called Olorofim compared to AmBisome® followed by standard care in patients with invasive Aspergillus infections. It aims to see if Olorofim can be a better option for those who cannot take mould-active azoles.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components and liver issues. There may also be risks associated with infusion treatments such as discomfort at the injection site or systemic reactions.
OASIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with invasive aspergillosis.
OASIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 10, day 14, day 21, day 28, day 42, day 56, day 70, day 84, and at eot (end of treatment - maximum treatment 84 days [± 7 days])
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10, day 14, day 21, day 28, day 42, day 56, day 70, day 84, and at eot (end of treatment - maximum treatment 84 days [± 7 days])
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause mortality
Secondary outcome measures
Adjudicated Assessment of Overall outcome
Data Review Committee's Assessment of Patient Mortality
Diagnosis of a secondary fungal infection
+6 moreOASIS Trial Design
2Treatment groups
Active Control
Group I: OlorofimActive Control1 Intervention
Olorofim versus AmBisome followed by Standard of Care (SOC)
Group II: AmBisomeActive Control1 Intervention
Olorofim versus AmBisome followed by Standard of Care (SOC)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Invasive Aspergillosis (IA) include antifungal agents such as voriconazole, amphotericin B, and the newer agent olorofim. Voriconazole works by inhibiting the enzyme 14-alpha-demethylase, crucial for ergosterol synthesis, thereby disrupting fungal cell membrane integrity.
Amphotericin B binds to ergosterol in the fungal cell membrane, creating pores that lead to cell death. Olorofim, a novel agent, inhibits dihydroorotate dehydrogenase, disrupting pyrimidine biosynthesis, which is essential for fungal DNA and RNA synthesis.
These mechanisms are vital for IA patients as they target critical fungal processes, reducing fungal load and improving patient outcomes.
In vitro activity of the novel antifungal olorofim against dermatophytes and opportunistic moulds including Penicillium and Talaromyces species.
In vitro activity of the novel antifungal olorofim against dermatophytes and opportunistic moulds including Penicillium and Talaromyces species.
Find a Location
Who is running the clinical trial?
ShionogiIndustry Sponsor
116 Previous Clinical Trials
41,261 Total Patients Enrolled
F2G Biotech GmbHLead Sponsor
20 Previous Clinical Trials
1,611 Total Patients Enrolled
11 Trials studying Invasive Aspergillosis
303 Patients Enrolled for Invasive Aspergillosis
Iqvia Pty LtdIndustry Sponsor
108 Previous Clinical Trials
171,775 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a serious allergic reaction or bad side effects from any part of the study drug.My heart's electrical cycle is longer than normal or I'm at high risk for it.I am HIV positive but not on antiretroviral therapy.I have liver problems.I am not pregnant or breastfeeding.I have been diagnosed with invasive aspergillosis.I have a fungal infection that is not candidiasis but can be treated with fluconazole.I am over 18 years old and weigh more than 40 kg.I need a different antifungal treatment because the usual one doesn't work for me.I have a chronic form of aspergillosis.I am suspected to have a fungal infection known as mucormycosis.I am using echinocandin for fungal infection prevention.AmBisome® is suitable for my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Olorofim
- Group 2: AmBisome
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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