Olorofim Aspergillus Infection Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
F2G Biotech GmbH
Study ID
NCT05101187
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Invasive Aspergillosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olorofim — DRUG
    Loading Dose: 5 tablets (150 mg) to be taken twice daily at a 12-hour (± 1 hour) interval on Day 1 Maintenance Dose: 3 tablets (90 mg) to be taken twice daily at 12-hour (± 1 hour) intervals from Day 2 until Day 84 (± 7 days)
  • AmBisome® — DRUG
    Initial course of at least 10 days of AmBisome® administered daily at a dose of 3 mg/kg by IV infusion over a 30- to 60-minute period or according to local guidelines Administration of SOC will follow international, national, or local guidelines and product labelling.

Study Details

The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).

Key Dates

Start date
Mar 31, 2022
Status verified
Jan 2026
Primary completion
Nov 18, 2025
Completion
Nov 1, 2026

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Olorofim
    Olorofim versus AmBisome followed by Standard of Care (SOC)
  • Active Comparator: AmBisome
    Olorofim versus AmBisome followed by Standard of Care (SOC)

Primary Outcome Measure

All-cause mortality [ Time Frame: Treatment Day 42 ]

Locations (24)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
City of Hope National Medical CenterDuarteCalifornia91010-
University of California Davis Health SystemSacramentoCalifornia95817-
UCSF Helen Diller Medical Center at Parnassus HeightsSan FranciscoCalifornia94143-
University of FloridaGainesvilleFlorida32610-
Augusta UniversityAugustaGeorgia30912-
University of Chicago Medical CenterChicagoIllinois60637-
University of Kansas Medical CenterKansas CityKansas64111-
The Johns Hopkins HospitalBaltimoreMaryland21287-
NIH Clinical Center ,NIAID,NIHBethesdaMaryland20892-
Massachusetts General HospitalBostonMassachusetts02114-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Mayo Clinic - RochesterRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Clairvoyant Research Group, LLCLas VegasNevada89119-
Rutgers RWJMSNew BrunswickNew Jersey08901-
Weill Cornell Medicine NY Presbyterian HospitalNew YorkNew York10065-
University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Duke Department of Medicine Infectious Diseases DivisionDurhamNorth Carolina27710-
OU Health OU Medical CenterOklahoma CityOklahoma73104-
University of Pittsburgh Medical Center Health SystemPittsburghPennsylvania15232-
Houston MethodistHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109-1024-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope National Medical Center· Duarte, CAUniversity of California Davis Health System· Sacramento, CAUCSF Helen Diller Medical Center at Parnassus Heights· San Francisco, CAUniversity of Florida· Gainesville, FLAugusta University· Augusta, GA

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