← Back to Search

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 below
Select...
I have been diagnosed with invasive aspergillosis.

OASIS Trial Timeline

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])
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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]) for reporting.

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 more

OASIS 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)

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
107 Previous Clinical Trials
169,843 Total Patients Enrolled

Media Library

AmBisome® (Liposomal Amphotericin B) Clinical Trial Eligibility Overview. Trial Name: NCT05101187 — Phase 3
Invasive Aspergillosis Research Study Groups: Olorofim, AmBisome
Invasive Aspergillosis Clinical Trial 2023: AmBisome® Highlights & Side Effects. Trial Name: NCT05101187 — Phase 3
AmBisome® (Liposomal Amphotericin B) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05101187 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining for enrollment in this experiment?

"Data hosted on clinicaltrials.gov reveals that this clinical trial is currently recruiting participants, having been first posted on March 31st 2022 and most recently edited December 16th 2022."

Answered by AI

What clinical applications has Olorofim been known to effectively treat?

"Olorofim has proven to be a successful line of defence against penicillium marneffei infection, invasive fungal infections, and severe mucocutaneous leishmaniasis."

Answered by AI

Has Olorofim been tested in any other scientific experiments?

"Olorofim was first investigated at the Institute Rotary Cancer Hospital in 2008, with 57 trials completed since then. At present time there are 9 studies actively recruiting participants--many of which are found around Las Vegas, Nevada."

Answered by AI

How many medical facilities are participating in this research endeavor?

"This research is taking place at Clairvoyant Research Group, LLC in Las Vegas, Nevada, University of Pittsburgh Medical Center Health System in Pennsylvania and University of Alberta Hospital in Edmonton. In addition to these locations there are several other sites that are participating as well."

Answered by AI

What is the scope of participation for this medical experiment?

"To ensure the success of this study, Iqvia Pty Ltd, who is sponsoring it, demands a total of 225 candidates that meet all the criteria. These participants are to be recruited from centres such as Clairvoyant Research Group in Las Vegas and University of Pittsburgh Medical Centre Health System in Pennsylvania."

Answered by AI

To what extent could Olorofim pose a hazard to those exposed?

"Olorofim has been evaluated extensively and received a score of 3 on our 1-3 scale, signifying that there is ample evidence in support of its safety profile. This drug is presently undergoing Phase 3 clinical trials to further evaluate efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Olorofim Aspergillus Infection Study
2022. "Olorofim Aspergillus Infection Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05101187.
~31 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top