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Ongoing Clinical Trials for Systemic Candida

There are currently 4 ongoing clinical trials investigating new treatments for systemic Candida infections, including candidemia and invasive candidiasis. These studies are taking place across several European countries and are evaluating both new antifungal medications and novel approaches to treating these serious bloodstream and systemic fungal infections. (Also known as: Invasive Candidiasis, Candidemia)

Clinical trial locations

Study on Rezafungin Levels in Critically Ill Patients with Invasive Candidiasis Undergoing ECMO or RRT

This trial is evaluating how the antifungal medication Rezafungin behaves in the body of critically ill patients who are receiving advanced life support treatments. The study focuses specifically on patients undergoing extracorporeal membrane oxygenation (ECMO), which is a machine that helps with breathing and circulation, with or without renal replacement therapy (RRT), which assists when the kidneys are not functioning properly.

Main inclusion criteria: Participants must be adults aged 18 or older who are in an intensive care unit, receiving ECMO support with or without RRT, and being treated with Rezafungin for the infection. Written informed consent is required, though if a patient is unconscious, consent can be obtained after they regain consciousness.

Main exclusion criteria: Patients who do not have invasive candidiasis, are not receiving ECMO or RRT, are not critically ill, or fall outside the specified age range cannot participate. The study also excludes individuals not considered part of a vulnerable population.

Focus of the trial: The main goal is to understand how Rezafungin is absorbed, distributed, and eliminated from the body during these advanced medical treatments. Researchers will monitor blood levels of the medication and evaluate how factors like additional treatments, body weight, and gender affect drug concentrations. The study also tracks side effects and how well patients tolerate the treatment.

Investigational drug: Rezafungin is an echinocandin antifungal medication that stops fungal growth by inhibiting a key component of the fungal cell wall. It is administered as an intravenous infusion at a dose of 200 mg.

Study on the Effectiveness and Safety of Fosmanogepix Compared to Caspofungin and Fluconazole for Adults with Candidemia or Invasive Candidiasis

This international trial compares a new treatment approach using fosmanogepix against the standard combination of caspofungin and fluconazole. The study evaluates whether the new medication is as effective and safe as current standard treatments.

Main inclusion criteria: Participants must be at least 18 years old and provide signed informed consent. They must have a confirmed diagnosis of candidemia or invasive candidiasis within the last 96 hours before entering the study, with positive tests showing Candida in the blood or other normally sterile areas. Clinical signs such as fever, low blood pressure, rapid breathing, rapid heart rate, or local infection signs must be present. The patient’s condition must allow for infection control measures like removing catheters if needed.

Main exclusion criteria: The study excludes patients with known allergies to study drugs, those already participating in another trial, individuals with certain serious medical conditions, pregnant or breastfeeding women, and those who have recently received medications that might interfere with the study drugs. Patients with a history of drug or alcohol abuse or any condition making them unsuitable for the study are also excluded.

Focus of the trial: The study aims to determine whether treatment starting with intravenous fosmanogepix followed by oral fosmanogepix is as effective as the standard approach of intravenous caspofungin followed by oral fluconazole. Participants receive regular monitoring through blood tests and clinical assessments to track treatment response and side effects.

Investigational drugs: Fosmanogepix is given first through intravenous infusion, then as oral tablets. It targets a specific enzyme in fungal cells that is crucial for their survival. Caspofungin, an established echinocandin medication, is given intravenously and works by inhibiting fungal cell wall synthesis. Fluconazole, an azole antifungal, is taken orally and interferes with fungal cell membrane production.

Study of Recombinant Interferon-Gamma 1b Combined with Standard Treatment for Patients with Candidemia: Safety and Effectiveness Evaluation

This study explores an innovative approach that combines standard antifungal treatment with recombinant interferon gamma-1b, a medication that enhances the immune system’s ability to fight fungal infections. The trial investigates whether adding this immune-boosting treatment helps clear the infection more effectively.

Main inclusion criteria: Participants must be between 18 and 75 years old. They must have at least one positive blood test for Candida within the last 120 hours and show signs of infection such as fever above 37.8°C, low blood pressure, or visible signs of inflammation. Female participants of childbearing age must use barrier contraception during the study and take a pregnancy test before starting. All participants must sign an informed consent form or have a legal representative do so.

Main exclusion criteria: The study excludes patients under 18 or over 75 years old, pregnant or breastfeeding women, and those with known allergies to interferon gamma. Individuals with active autoimmune diseases, severe liver or kidney dysfunction, life-threatening conditions requiring intensive care, very low white blood cell counts, active cancer undergoing chemotherapy, history of organ transplantation, severe heart conditions, HIV infection or severe immunodeficiency, seizure history, or severe neurological disorders cannot participate.

Focus of the trial: The main goal is to determine if adding recombinant interferon gamma-1b to standard therapy helps clear Candida from the bloodstream more quickly, particularly within the first seven days of treatment. The study monitors blood cultures regularly and tracks overall health status, nutrition measurements, organ function, and any side effects throughout the treatment period of up to two months.

Investigational drugs: Recombinant interferon gamma-1b is a laboratory-made protein that stimulates immune cells to fight infections more effectively. It is administered as a subcutaneous injection (under the skin) at doses up to 50 micrograms per square meter of body surface. Standard antifungal therapy, which typically includes fluconazole, echinocandins, or amphotericin B, is used alongside the investigational medication.

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

This trial compares two oral antifungal medications used after initial intravenous treatment. The study evaluates whether ibrexafungerp, a newer antifungal agent, is as effective as the well-established medication fluconazole in continuing treatment after the initial phase.

Main inclusion criteria: Participants must be adults at least 18 years old. They must have a confirmed diagnosis of candidemia or invasive candidiasis, with evidence of Candida in blood or tissue samples from normally sterile body areas. This sample must be taken within four days of starting intravenous echinocandin treatment. Participants must also show related symptoms such as fever higher than 38°C, low blood pressure, or signs of inflammation.

Main exclusion criteria: The study excludes patients with known allergies to study medications, those with a history of liver disease, individuals currently taking medications that could interfere with study drugs, pregnant or breastfeeding women, and those with weakened immune systems. Patients who participated in another trial within the last 30 days, have a history of alcohol or drug abuse, certain heart conditions, recent or planned surgery, or severe kidney disease are also excluded.

Focus of the trial: The study determines whether the treatment sequence of intravenous echinocandin followed by oral ibrexafungerp is as effective as intravenous echinocandin followed by oral fluconazole. Participants undergo regular health monitoring throughout the study period of up to six months, with assessments focusing on treatment response and potential side effects.

Investigational drugs: Echinocandin is an intravenous antifungal medication used as the initial treatment. Ibrexafungerp is a triterpenoid antifungal taken orally in tablet form that works by inhibiting fungal cell wall synthesis. Fluconazole, also taken orally in capsule form, is an azole antifungal that disrupts fungal cell membrane production by inhibiting a key enzyme.

Summary

All four ongoing clinical trials for systemic Candida infections focus on improving treatment options for these serious fungal infections. The trials are spread across multiple European countries, with the strongest concentration in Germany, Greece, Belgium, France, Italy, and Spain, reflecting a coordinated European effort to advance treatment options.

Three of the four trials evaluate new or alternative antifungal medications, including rezafungin, fosmanogepix, and ibrexafungerp, comparing them to established treatments like fluconazole and caspofungin. One trial takes an innovative approach by testing an immune-boosting therapy (recombinant interferon gamma-1b) combined with standard antifungal treatment.

The trials address different patient populations, ranging from critically ill patients receiving advanced life support to adults with confirmed bloodstream or systemic Candida infections. Most studies require participants to be at least 18 years old and have confirmed Candida infections with clinical symptoms. Common exclusion criteria across trials include pregnancy, severe allergies to study medications, and participation in other clinical trials.

These studies represent important steps toward developing more effective treatment strategies for invasive candidiasis and candidemia, conditions that can lead to serious complications if not properly managed.

Ongoing Clinical Trials on Systemic candida

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