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Ongoing Clinical Trials for Fungal Infection

Currently, there are 8 clinical trials exploring various treatments and prevention strategies for fungal infections across multiple European countries. These studies investigate antifungal medications including fluconazole, posaconazole, olorofim, fosmanogepix, and rezafungin in different patient populations, from newborns to adults undergoing complex medical procedures.

Clinical trial locations

Study on Fluconazole and Sodium Chloride to Prevent Fungal Infections in Patients Undergoing Cystectomy

This trial evaluates whether fluconazole can reduce complications from invasive fungal infections in patients undergoing bladder removal surgery. The medication is administered as an intravenous infusion and compared against a placebo.

Main inclusion criteria: Patients must be over 18 years old, able to understand and provide informed consent in Danish, and scheduled for cystectomy with ileal conduit urinary diversion. A cystectomy is a surgical procedure to remove the bladder, while an ileal conduit uses a small piece of intestine to create a new pathway for urine to leave the body.

Main exclusion criteria: Patients with an existing fungal infection or belonging to vulnerable populations cannot participate in this study.

Focus of the trial: The primary goal is to determine whether fluconazole given as a preventive treatment can effectively reduce post-surgical complications. Researchers will monitor patients for 90 days after surgery, tracking various outcomes including days alive and out of hospital, digestive system recovery time, quality of life, hospital stay length, and any infections requiring treatment.

Investigational drug: Prophylactic antimycotic medicine (fluconazole) is used to prevent fungal infections during the recovery period following cystectomy. Fluconazole works by disrupting fungal cell membrane formation, preventing fungus growth.

Study on Posaconazole for Treating Fungal Infections in Children Under 2 Years

This study investigates how posaconazole is processed in the bodies of very young children with serious invasive fungal infections. The medication is tested in two forms: an oral suspension taken by mouth and a solution given through a vein.

Main inclusion criteria: Children must have a central line in place or planned, weigh at least 500 grams, and have documented informed consent from a legally acceptable representative. For Panel A, children must be receiving treatment for possible, probable, or confirmed invasive fungal infection that posaconazole can fight against, including candidiasis. For Panel B, children must have a diagnosis of invasive fungal infection caused by fungi that posaconazole can combat, excluding candidiasis.

Main exclusion criteria: The specific exclusion criteria are determined by the medical team based on each child’s individual health status and other medications they may be taking.

Focus of the trial: Researchers aim to understand how posaconazole is absorbed and processed in children under two years old, while closely monitoring safety and any side effects. The study is divided into panels, with some children receiving single doses and others receiving multiple doses over time.

Investigational drug: Posaconazole is given either intravenously or as oral powder for suspension. It works by inhibiting ergosterol synthesis, a vital component of fungal cell membranes, thereby disrupting membrane integrity and killing fungal cells.

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

This trial compares two treatments for invasive aspergillosis, a serious fungal infection caused by Aspergillus species. Patients receive either olorofim tablets or AmBisome infusions followed by standard care.

Main inclusion criteria: Patients must be at least 18 years old and weigh at least 30 kilograms. They need confirmed or likely Aspergillus infection in any part of the body or in the lower lungs, with treatment not exceeding 28 days. Patients require antifungal medicine that is not an azole type and should have had no more than 96 hours of previous potentially effective treatment. This includes cases of proven or suspected azole resistance, infection occurring despite azole preventive treatment, medical reasons making azoles unsuitable, or infection not improving with azole treatment. AmBisome must be suitable for the patient, and patients must be able and willing to follow study rules. Female patients must not be breastfeeding or at risk of pregnancy, while male patients with partners who can become pregnant must use effective contraception or practice abstinence.

Main exclusion criteria: Patients with infections not caused by Aspergillus, those outside the specified age range, those unable to follow study procedures, those with conditions making participation unsafe, pregnant or breastfeeding women, participants in other clinical trials, those with severe allergic reactions to similar medications, substance abuse history, mental health conditions affecting participation, or serious heart conditions.

Focus of the trial: The study evaluates effectiveness and safety over up to 91 days, monitoring overall treatment response, survival rates, and quality of life. Assessments occur at multiple timepoints including Days 14, 28, 42, 84, and at treatment completion.

Investigational drugs: Olorofim tablets are compared with AmBisome (liposomal amphotericin B) infusions. Olorofim inhibits an enzyme essential for fungal cell wall synthesis, while AmBisome binds to fungal cell membranes causing them to become porous, leading to cell death.

Study of fosmanogepix compared to standard antifungal drugs for treating invasive mold infections in adults

This study evaluates fosmanogepix for treating serious mold infections caused by various fungi including Aspergillus, Fusarium, Lomentospora prolificans, and Mucorales. The medication is given both as an intravenous infusion and oral tablets.

Main inclusion criteria: Adults (18 years or older) with confirmed invasive mold infection caused by specific fungi, particularly in patients with limited treatment options. The infection must be either proven through laboratory tests or highly probable based on medical evidence. Patients must be in a condition allowing proper treatment of the infection source.

Main exclusion criteria: Age below 18 years, pregnancy or breastfeeding, severe allergic reactions to similar medications, severe liver or kidney problems, active cancer treatment interfering with the study medication, medications that could interact with the study drug, inability to take oral medications, participation in another trial within 30 days, conditions making participation unsafe, aspergillosis resistant to all available treatments, severe or unstable heart conditions, history of organ transplantation, active hepatitis B or C, or HIV infection with inadequate immune function.

Focus of the trial: The study monitors patient survival and recovery from infections over a treatment period lasting up to 180 days. Doctors track clinical symptoms, laboratory tests, and imaging scans to evaluate treatment response. Regular assessments include heart monitoring and neurological checks. Response evaluation occurs on days 42 and 84, with a follow-up period lasting 6 weeks after treatment completion.

Investigational drug: Fosmanogepix is an antifungal medication designed to fight various types of mold infections difficult to treat with other medications. It targets the fungal cell wall through a unique mechanism, offering a potential solution for multidrug-resistant infections.

Study on Fluconazole for Children and Adolescents with Fungal Infections

This trial studies how fluconazole works in children and adolescents aged 2 to 18 years with invasive fungal infections. The medication is given either orally or through intravenous infusion.

Main inclusion criteria: Patients must be treated with fluconazole for preventing or treating serious fungal infections, be between 2 and 18 years old when first receiving fluconazole, and have a central venous catheter or arterial line for blood sampling and medication administration.

Main exclusion criteria: Patients with current or recent fungal infection outside the study parameters, those not within the 2-18 year age range, those unable to follow study procedures or take medication as required, those with medical conditions making participation unsafe, pregnant or breastfeeding patients, and those participating in another clinical trial simultaneously.

Focus of the trial: Researchers observe how the body processes fluconazole, including absorption, distribution, and clearance. The study aims to establish optimal dosing guidelines for young patients, ensuring effective and safe medication use. Factors affecting medication effectiveness such as body weight and kidney function are explored.

Investigational drug: Fluconazole is available as capsules, oral suspension, or solution for infusion. It works by interfering with fungal cell membrane formation, specifically preventing ergosterol production essential for fungal survival.

Study on Posaconazole and Fluconazole for Preventing Fungal Infections in Patients with Acute Myeloid Leukemia

This trial compares posaconazole and fluconazole for preventing fungal infections in patients with acute myeloid leukemia, a blood and bone marrow cancer. The study determines whether posaconazole is more effective than fluconazole in reducing invasive mold infection risk.

Main inclusion criteria: Patients must provide signed informed consent, be 18 years or older, have an AML or MDS diagnosis, be receiving intensive chemotherapy (induction, consolidation, or salvage), and have planned hospital admission for the neutropenic phase when white blood cell count is very low (ANC less than 500 cells/mm³).

Main exclusion criteria: Patients without AML diagnosis, those outside the specified age range, those unable to follow study procedures, those with known allergies to posaconazole or fluconazole, pregnant or breastfeeding women, those participating in another clinical trial, or those with other medical conditions making participation unsafe.

Focus of the trial: Participants are randomly assigned to receive either posaconazole or fluconazole preventively, with some potentially receiving a placebo. The treatment period lasts up to 180 days, during which fungal infection occurrence is monitored. Close observation for side effects or adverse reactions continues throughout the study.

Investigational drugs: Posaconazole prevents fungal infections by stopping fungal growth through ergosterol synthesis inhibition. Fluconazole prevents and treats infections by interfering with fungal cell membrane formation. The study compares their effectiveness in preventing mold infections in AML patients.

Study on Rezafungin Acetate for Children with Fungal Infections Aged Birth to Under 18 Years

This study evaluates rezafungin acetate in children from birth to under 18 years already receiving other antifungal treatments. The medication is given as a single intravenous infusion dose.

Main inclusion criteria: Children from birth up to 18 years old, both boys and girls, who are receiving systemic antifungal medication either orally or through IV to prevent or treat fungal infections.

Main exclusion criteria: Known allergies to the study medication or ingredients, current participation in another clinical trial, severe liver or kidney problems, pregnancy or breastfeeding, history of drug or alcohol abuse, certain heart conditions, recent use of medications interfering with the study drug, or other medical conditions making participation unsafe.

Focus of the trial: Researchers study how the body processes this medication and assess its safety and tolerability in children. Participants undergo various health checks including blood tests and heart monitoring to ensure safety. A single dose is given, followed by close monitoring for any side effects or health changes.

Investigational drug: Rezafungin acetate is delivered intravenously to help prevent or treat fungal infections. It interferes with fungal cell walls, which are essential for fungal survival, ultimately leading to fungal death.

Study on Rezafungin to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

This trial compares rezafungin against standard antimicrobial treatments for preventing invasive fungal diseases in adults undergoing allogeneic blood and marrow transplantation. The goal is to evaluate whether rezafungin can help patients survive without fungal infections for 90 days after transplant.

Main inclusion criteria: Patients must provide written informed consent, be 18 years or older, and be receiving HLA-matched or mismatched allogeneic peripheral blood and marrow transplant from various donor types. Eligible diagnoses include acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, myelodysplastic syndromes, lymphoma, aplastic anemia, myelofibrosis, chronic myelomonocytic leukemia, chronic lymphocytic leukemia, sickle cell anemia, red blood cell aplasia, myeloproliferative disorder, or multiple myeloma. Patients must receive myeloablative or reduced-intensity conditioning regimens and have adequate liver and kidney function before conditioning. Females of childbearing potential must use effective contraception, and males must use barrier contraception or practice abstinence. Baseline blood samples and tests must be completed within specified timeframes.

Main exclusion criteria: Known allergies to study medications, current participation in other clinical trials, certain serious medical conditions interfering with the study, pregnancy or breastfeeding, current infections requiring interfering medications, recent treatments affecting study results, substance abuse history, or conditions making patients unsuitable for participation.

Focus of the trial: Participants receive either rezafungin or standard antimicrobial regimen (which may include Bactrim, Diflucan, or Noxafil). Some may receive a placebo. The study monitors survival and absence of fungal infections for 90 days, tracking infection numbers and deaths during the study period. Regular assessments ensure participant safety.

Investigational drug: Rezafungin for injection is compared to standard antimicrobial regimen to determine if it is equally or more effective at keeping patients fungal infection-free 90 days after transplant. Rezafungin inhibits essential fungal cell wall component synthesis, preventing fungal growth and survival.

Summary

These eight clinical trials represent diverse approaches to managing fungal infections across different patient populations. Several countries show significant concentration of research activity, with Belgium, France, Germany, Spain, and Italy each hosting multiple trials. This geographic distribution suggests strong European collaboration in advancing antifungal treatment research.

A notable focus emerges on preventing infections in vulnerable populations, particularly patients undergoing major procedures like blood and marrow transplantation or bladder removal surgery. Multiple trials also address pediatric populations, ranging from newborns to adolescents, highlighting the need for age-appropriate treatment approaches.

The investigational medications span both established drugs like fluconazole and posaconazole being studied in new contexts, and novel agents such as olorofim, fosmanogepix, and rezafungin. Several trials specifically target difficult-to-treat invasive mold infections or evaluate preventive strategies in immunocompromised patients.

Many studies emphasize pharmacokinetic evaluation—understanding how medications are absorbed and processed in the body—to optimize dosing regimens. This is particularly important for pediatric populations and patients undergoing intensive medical treatments that may affect drug metabolism.

Ongoing Clinical Trials on Fungal infection

  • Study of caspofungin compared to placebo for treating yeast infections in the abdomen in intensive care unit patients

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Fluconazole and Sodium Chloride to Prevent Fungal Infections in Patients Undergoing Cystectomy

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Posaconazole and Fluconazole for Preventing Fungal Infections in Patients with Acute Myeloid Leukemia

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

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