Study on the Effectiveness and Safety of Olorofim vs. Liposomal Amphotericin B for Patients with Invasive Aspergillosis

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What is this study about?

This clinical trial is focused on studying a serious condition known as invasive aspergillosis, which is a type of fungal infection caused by the Aspergillus species. The study aims to evaluate the effectiveness and safety of two treatments for this infection. The first treatment being tested is a medication called Olorofim, which is taken in tablet form. The second treatment involves the use of AmBisome, a form of liposomal amphotericin B, which is administered through an infusion into the veins. The purpose of the study is to compare these two treatments to see which one is more effective and safer for patients with this type of fungal infection.

Participants in the study will be randomly assigned to receive either Olorofim or AmBisome followed by standard care. The study will last for a period of up to 91 days, during which the health and progress of the participants will be closely monitored. The study will assess various outcomes, including the overall response to the treatment and the survival rate of the participants. The study will also look at the quality of life of the participants during and after the treatment period.

This trial is designed to provide valuable information on the best treatment options for patients suffering from invasive aspergillosis. By comparing the two treatments, researchers hope to find the most effective way to manage this serious infection and improve patient outcomes. Participants will be under the care of medical professionals throughout the study to ensure their safety and well-being.

1 Joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, weight, and medical condition related to invasive fungal infections caused by Aspergillus species.

Participants must be able to comply with the study protocol and meet specific health and safety requirements.

2 Initial treatment phase

Participants are randomly assigned to receive either AmBisome or Olorofim as initial treatment.

AmBisome is administered as a dispersion for infusion through intravenous use. The dosage and frequency are determined by the study protocol.

Olorofim is provided in tablet form for oral use. The dosage and frequency are specified by the study protocol.

3 Monitoring and assessment

Participants undergo regular assessments to monitor the response to treatment. This includes clinical evaluations, radiological imaging, and laboratory tests.

The primary focus is on the rate of all-cause mortality at Day 42, with additional assessments at Days 14, 28, 42, 84, and at the end of treatment (EOT).

4 Follow-up phase

After completing the treatment phase, participants enter a follow-up period to evaluate long-term outcomes and any potential secondary infections.

Quality of life is assessed using a standardized questionnaire at baseline, Day 14, and EOT.

5 Completion of the study

The study concludes with a final evaluation of the participant’s health status and overall response to the treatment.

The estimated end date for the study is November 28, 2025.

Who Can Join the Study?

Patients must be male or female, at least 18 years old, and weigh at least 30 kg. If a patient cannot read or write, they must fully understand the information given by the study doctor.
Patients must have a confirmed or likely infection caused by a fungus called Aspergillus in any part of the body or in the lower lungs. The treatment for this infection should not have lasted more than 28 days.
Patients need treatment with an antifungal medicine that is not a type called azole. They should have had no more than 96 hours of previous treatment that might work against the infection. This includes:
- Proven or suspected resistance to azole medicines.
- Infection that occurred despite taking azole medicines to prevent it.
- Any other medical reason why azole medicines are not suitable.
- Infection that does not improve with azole treatment, with no more than 28 days of previous treatment.
The medicine AmBisome® must be suitable for the patient. Previous treatment with amphotericin B (like AmBisome®) is allowed if it follows the rules for treatment duration.
Patients must be able and willing to follow the study rules.
Female patients must not be breastfeeding and must not be at risk of becoming pregnant.
Male patients with female partners who can become pregnant must either not have sexual intercourse or use a very effective form of birth control.

Who Cannot Join the Study?

Patients who have a different type of infection that is not caused by the Aspergillus fungus.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a severe allergic reaction to similar medications in the past.
Patients who have a history of substance abuse that could interfere with the study.
Patients who have a mental health condition that could affect their ability to participate in the study.
Patients who have a serious heart condition that could be worsened by the study medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
Hopital Necker Enfants Malades	Paris	France
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
National Institute For Infectious Diseases Lazzaro Spallanzani	Rome	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universita Cattolica Del Sacro Cuore	Rome	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Hospital Clinic De Barcelona	Barcelona	Spain
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Usmsifuysk Mzhkwjx Czdznu Haxsvonjmcpikgrta	Hamburg	Germany
Cxmksqk Uhdgbfrualfmzptkjyh Bzygxi – Cdlwuf Bjtfaqbi Fahsotdr	Berlin	Germany
Uqemdxfxlvzgaevigttd Kalb Zafuhud fmub Kjufdmxte Slmnyvm &nwnfkt Zva	Cologne	Germany
Slvckedwy Rmwynra Uajjxnvych Mopqfre Cjxgja	Nijmegen	The Netherlands
Bfgstcrs Ufesrqlgnk Huiukseq Clgisn	Besançon	France
Fgbhivhoo Pdeh Ls Ipgoxnerjxupa Butsjecou Dyd Hqtlhxym Ulwmonamkihjm Lc Ptq	Madrid	Spain
Hfzhyahb Vgpi dhuhedpv	Barcelona	Spain
Hblnrjds Ueeajhovairnmo Suiqykuebk &pxqyys Hwklrtr dy Hiztqfkwjak	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	06.09.2022
France	Not recruiting	06.09.2022
Germany	Not recruiting	06.09.2022
Italy	Not recruiting	06.09.2022
Spain	Not recruiting	06.09.2022
The Netherlands	Not recruiting	06.09.2022

Trial locations

Investigated drugs:

Olorofim is a medication being studied for its effectiveness and safety in treating invasive fungal disease caused by Aspergillus species. It is being compared to other treatments to see if it can help patients recover from these serious infections.

AmBisome is a medication used in the trial as a treatment for invasive fungal disease. It is often used as an initial treatment before switching to other standard care options. The trial aims to see how well it works compared to olorofim in treating infections caused by Aspergillus species.

Investigated diseases:

Fungal infection

Invasive Aspergillosis – This is a serious infection caused by the Aspergillus fungus, which is commonly found in the environment. It primarily affects individuals with weakened immune systems, such as those undergoing chemotherapy or organ transplants. The infection typically begins in the lungs, as the spores are inhaled, and can spread to other parts of the body, including the brain, heart, and kidneys. Symptoms may include fever, cough, chest pain, and difficulty breathing. As the disease progresses, it can lead to severe respiratory issues and other complications. Early detection and management are crucial to prevent further spread and damage.

Trial ID:

2024-513030-38-00

Protocol code:

F901318/0041

NCT ID:

NCT05101187

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Olorofim vs. Liposomal Amphotericin B for Patients with Invasive Aspergillosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?