Study Comparing Ibrexafungerp and Fluconazole for Treating Candidemia or Invasive Candidiasis in Patients

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What is this study about?

This clinical trial is focused on studying the treatment of Invasive Candidiasis and Candidemia, which are serious infections caused by a type of yeast called Candida. The study aims to compare two treatment regimens. The first regimen involves using an intravenous medication called echinocandin, followed by an oral medication named Ibrexafungerp (also known by its code name, SCY-078). The second regimen also starts with intravenous echinocandin but is followed by an oral medication called Fluconazole. A placebo, which looks like the real medication but does not contain the active ingredient, is also used in the study for comparison purposes.

The purpose of the study is to determine if the treatment with intravenous echinocandin followed by oral Ibrexafungerp is as effective as the treatment with intravenous echinocandin followed by oral Fluconazole. Participants in the study will receive one of these treatment regimens. The study will last for a period of up to six months, during which participants will be monitored for their response to the treatment and any side effects they may experience.

Throughout the study, participants will receive regular check-ups to assess their health and the effectiveness of the treatment. The study will help researchers understand which treatment regimen is more effective in treating Invasive Candidiasis and Candidemia, potentially leading to better treatment options for patients in the future.

1 initial treatment phase

Upon joining the study, the initial treatment involves the administration of an intravenous medication known as echinocandin. This medication is used to treat infections caused by a type of fungus called Candida.

The intravenous treatment is administered in a healthcare setting. The duration of this phase depends on the specific needs of the patient and the response to the treatment.

2 transition to oral medication

After the initial intravenous treatment, the patient transitions to an oral medication. The study involves two possible oral medications: ibrexafungerp or fluconazole.

The choice of oral medication is determined by the study protocol, and the patient will be randomly assigned to one of the two options.

3 oral medication regimen

If assigned to ibrexafungerp, the patient will take this medication orally in tablet form. The specific dosage and frequency will be provided by the healthcare team.

If assigned to fluconazole, the patient will take this medication orally in capsule form. The specific dosage and frequency will be provided by the healthcare team.

The duration of the oral medication phase is determined by the patient’s response to the treatment and the study protocol.

4 monitoring and follow-up

Throughout the study, the patient’s health and response to the treatment are closely monitored. This includes regular check-ups and assessments by the healthcare team.

The study aims to evaluate the effectiveness of the treatment regimens, focusing on the patient’s recovery and any potential side effects.

5 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation is conducted to assess the overall success of the treatment.

The evaluation includes clinical assessments, laboratory tests, and any necessary imaging studies to ensure the infection has been effectively treated.

Who Can Join the Study?

The participant must be an adult, which means they are a male or female who is at least 18 years old on the day they sign the study consent form.
The participant must have a diagnosis of candidemia or invasive candidiasis. This means there is evidence of a type of yeast called Candida in their blood or in a tissue sample from a part of the body that is usually free of germs. This sample must be taken within 4 days of starting treatment with a medicine called IV echinocandin. The participant must also show any related signs or symptoms, such as a fever higher than 38°C, low blood pressure, or signs of inflammation in the area.

Who Cannot Join the Study?

Patients who have a known allergy or severe reaction to the study medications cannot participate.
Individuals with a history of liver disease or liver problems may be excluded.
Patients who are currently taking medications that could interfere with the study drugs are not eligible.
Pregnant or breastfeeding women cannot take part in the study.
Individuals with a weakened immune system, such as those with HIV/AIDS, may be excluded.
Patients who have participated in another clinical trial within the last 30 days are not eligible.
Individuals with a history of alcohol or drug abuse may be excluded from the study.
Patients with certain heart conditions or heart problems may not be able to participate.
Individuals who have had a recent surgery or are planning to have surgery soon may be excluded.
Patients with severe kidney disease or kidney problems may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
University Hospital Jena KöR	Jena	Germany
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Centre Hospitalier Victor Dupouy	Argenteuil	France
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Del Mar	Barcelona	Spain
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Umbal – Prof. D-R Stoyan Kirkovich AD	Stara Zagora	Bulgaria
Evangelismos S.A.	Athens	Greece
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.	Plovdiv	Bulgaria
Hopital Beaujon	Clichy	France
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Czcvizufg Upfwzposljhoop Sejmlmmdt	Woluwe-Saint-Lambert	Belgium
Hvocngcf Ushvwenhrkdez Dq Lz Puolrgxx	Madrid	Spain
Obqmmlyeveiytsghhsvioekvdt	Aalst	Belgium
Lpels Glynrar Hzfwwtxt Ol Azrdpo	Athens	Greece
Ugwpluhdgi Hnqzainm Chiizul	Cologne	Germany
Ascmwtrwke Ppccptxc Hkgqdpuk Dk Pnwze	Paris	France
Gehpgo Untqvuajlb Frbpncgnl	Frankfurt	Germany
Ultnkgttdqualdbmryhmj Wucfpjunx Awj	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	03.08.2022
Bulgaria	Not recruiting	03.08.2022
France	Not recruiting	03.08.2022
Germany	Not recruiting	03.08.2022
Greece	Not recruiting	03.08.2022
Italy	Not recruiting	03.08.2022
Spain	Not recruiting	03.08.2022

Trial locations

Investigated drugs:

Echinocandin is a type of antifungal medication given through an intravenous (IV) infusion. It is used to treat serious fungal infections like candidemia and invasive candidiasis. In this trial, echinocandin is used as the initial treatment to help control the infection.

Ibrexafungerp is an oral antifungal medication that is used after the initial IV treatment with echinocandin. It is designed to continue fighting the fungal infection and prevent it from coming back. This medication is taken by mouth, making it easier for patients to continue their treatment outside of a hospital setting.

Fluconazole is another oral antifungal medication used in this trial. Like ibrexafungerp, it is taken after the initial IV treatment with echinocandin. Fluconazole helps to maintain control over the fungal infection and is a well-known treatment option for candidemia and invasive candidiasis.

Invasive Candidiasis – This is a serious fungal infection caused by Candida species that can enter the bloodstream and spread throughout the body. It often affects people with weakened immune systems or those in hospital settings. The infection can lead to symptoms such as fever and chills that do not improve with antibiotics. As it progresses, it can affect various organs, including the heart, brain, eyes, and bones. The disease requires prompt medical attention to prevent further complications. It is distinct from superficial Candida infections, which affect the skin or mucous membranes.

Trial ID:

2024-511755-18-00

Protocol code:

SCY-078-302

NCT ID:

NCT05178862

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ibrexafungerp and Fluconazole for Treating Candidemia or Invasive Candidiasis in Patients

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