Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Pill-Form fungus fighter takes on deadly candida

NCT ID NCT05421858

Disease control Sponsor: Basilea Pharmaceutica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 5 times

Summary

This Phase 3 trial tests a new drug called fosmanogepix against standard treatments for life-threatening Candida bloodstream or organ infections. About 450 adults will be randomly assigned to receive either fosmanogepix (first by IV, then as a pill) or the usual IV caspofungin followed by oral fluconazole. The main goal is to see if fosmanogepix works as well as the standard regimen at clearing the infection and keeping patients alive at 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fosmanogepix (given first by IV, then as a pill)
What this could lead to
If it works, this could offer a new treatment option for serious Candida infections, potentially with an easier switch from IV to oral pills.
What could go wrong
This is a large Phase 3 trial, but it's designed to show fosmanogepix is not worse than current drugs, not necessarily better. There's always a chance it may not meet that goal or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients ≥ 18 years (or the minimum country-specific age of consent if \> 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf. 2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization. 3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary. Exclusion Criteria: 1. Existing infection 1. Infection known to be due to Candida krusei, in blood or any other normally sterile site. 2. Inappropriate fungal infection source control. 3. Diagnosis of certain deep-seated Candida infections. 2. Life expectancy of \< 72 hours in the opinion of the investigator. 3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration. 4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary). 5. Patients with known human immunodeficiency virus infection, who have CD4+ count \< 200/mm3 or viral load \> 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening. 6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study. 7. Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication. 8. Received \> 2 days (\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., \> 2 doses of a once daily antifungal agent or \> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B). 9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer). 10. Prior participation in this or any previous study of fosmanogepix. 11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome. 12. Female patient is pregnant or lactating. 13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients. 14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Candidemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

candidemia candidiasis, invasive disseminated candidiasis fungal infectious disease Torulopsis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Candidemia Candidiasis, invasive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    144 sites in 20 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "LAIKO" General Hospital

    RECRUITING

    Athens, 115 27, Greece

  • "Sotiria" Chest Diseases Hospital of Athens

    RECRUITING

    Athens, 11527, Greece

  • AOU Senese

    RECRUITING

    Siena, 53100, Italy

  • Ajou University Hospital

    RECRUITING

    Suwon, 16499, South Korea

  • Amiens Picardie University Hospital - South, Intensive Care Unit (ICU)

    RECRUITING

    Amiens, 80054, France

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912-5563, United States

  • Big Metropolitan Hospital Niguarda Regional Health Authority

    RECRUITING

    Milan, 20162, Italy

  • British Sanatorium SA

    RECRUITING

    Rosario, S2000CVB, Argentina

  • Buenos Aires Italian Hospital, Department of Infectious Diseases

    RECRUITING

    Buenos Aires, C1199ABB, Argentina

  • Cardiomet CEQUIN Foundation, Department of Nephrology

    RECRUITING

    Armenia, 630004, Colombia

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Central Hospital Mendoza

    TERMINATED

    Mendoza, M5500IDN, Argentina

  • Central Hospital de San Isidro Melchor Posse

    RECRUITING

    Buenos Aires, B1641, Argentina

  • Central Hospital of Wuhan

    RECRUITING

    Wuhan, 430014, China

  • Chaim Sheba Medical Center, Department of Infectious Diseases

    RECRUITING

    Ramat Gan, 52621, Israel

  • China Medical University Hospital

    RECRUITING

    Taichung, 404327, Taiwan

  • China-Japan Friendship Hospital

    RECRUITING

    Beijing, 100029, China

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cordoba Private University Hospital, Department of Infectious Diseases

    RECRUITING

    Córdoba, X5016KEH, Argentina

  • DMC Harper University Hospital

    RECRUITING

    Detroit, Michigan, 48201, United States

  • David Geffen School of Medicine at UCLA

    RECRUITING

    Los Angeles, California, 90095, United States

  • Edith Wolfson Medical Center, Department of Infectious Diseases

    RECRUITING

    Holon, 58100, Israel

  • Emory University Hospital - Clifton Road

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Erasme Hospital, Department of Infectious and Tropical Diseases

    RECRUITING

    Brussels, B-1070, Belgium

  • Eurohospital University Hospital

    RECRUITING

    Plovdiv, 4004, Bulgaria

  • Far Eastern Memorial Hospital

    RECRUITING

    New Taipei City, 220, Taiwan

  • Frankfurt University Clinic

    RECRUITING

    Frankfurt am Main, Hesse, 60590, Germany

  • General Hospital Saint-Jan

    RECRUITING

    Bruges, 8000, Belgium

  • General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

    RECRUITING

    Athens, PC 10676, Greece

  • General Hospital of Thessaloniki "Ippokratio"

    RECRUITING

    Thessaloniki, 54642, Greece

  • Giuliano Isontina University Health Authority

    RECRUITING

    Trieste, 34125, Italy

  • Guangzhou First People's Hospital

    RECRUITING

    Guangzhou, 510180, China

  • HC-UFPR

    RECRUITING

    Curitiba, Paraná, 80060-900, Brazil

  • Helen Joseph Hospital

    SUSPENDED

    Johannesburg, 2092, South Africa

  • Henry Ford Hospital, Department of Medicine, Division of Infectious Diseases

    RECRUITING

    Detroit, Michigan, 48202, United States

  • High Technology Medical Institute S.A.S, IMAT S.A.S.

    RECRUITING

    Montería, 230002, Colombia

  • Hospital "S. Croce e Carle"

    RECRUITING

    Cuneo, 12100, Italy

  • Hospital Alma Mater de Antioquia

    RECRUITING

    Medellín, 050012, Colombia

  • Hospital Clinic of Barcelona, Department of Infectious Diseases

    RECRUITING

    Barcelona, Catalonia, 08036, Spain

  • Hospital Favoriten, Department of Internal Medicine IV - Infectious Diseases and Tropical Medicine

    RECRUITING

    Vienna, 1100, Austria

  • Hospital Our Lady of Grace

    RECRUITING

    Curitiba, Paraná, 80810-040, Brazil

  • Hospital San Raffaele, IRCCS

    RECRUITING

    Milan, 20132, Italy

  • Hospital del Mar, Department of Infectious Diseases

    RECRUITING

    Barcelona, Catalonia, 08003, Spain

  • Houston Methodist Hospital - Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Huashan Hospital

    RECRUITING

    Shanghai, 200040, China

  • IRCCS Policlinic Hospital San Martino

    RECRUITING

    Genoa, 16132, Italy

  • Indiana University Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, 301617, China

  • Italian Hospital of La Plata, Department of Infectious Diseases

    RECRUITING

    La Plata, B1900, Argentina

  • Jessa Hospital

    RECRUITING

    Hasselt, 3500, Belgium

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 833401, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807377, Taiwan

  • Kepler University Hospital GmbH, Department of Pulmonology, Clinical Department of Infectious Diseases

    RECRUITING

    Linz, 4021, Austria

  • Kyungpook National University Hospital

    SUSPENDED

    Daegu, 41944, South Korea

  • Linkou Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan City, 333, Taiwan

  • Lishui People's Hospital

    RECRUITING

    Lishui, 323000, China

  • Liuzhou People's Hospital

    RECRUITING

    Liuzhou, 530021, China

  • Luz Castro de Gutierrez Medellin General Hospital, Research Center

    RECRUITING

    Medellín, 050015, Colombia

  • Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda

    RECRUITING

    Milan, 20122, Italy

  • Maharaj Nakorn Chiang Mai Hospital

    RECRUITING

    Chiang Mai, 50200, Thailand

  • Marseille Nord University Hospitals - AP-HM, Medical Intensive Care Unit, Acute Respiratory Distress and Severe Infections

    SUSPENDED

    Marseille, 13015, France

  • Medical University Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Milpark Hospital

    RECRUITING

    Johannesburg, 2193, South Africa

  • Monash Medical Center Clayton

    RECRUITING

    Clayton, 3168, Australia

  • Nantes University Hospital Center - Hotel Dieu Hospital, Department of Infectious and Tropical Diseases

    RECRUITING

    Nantes, 44000, France

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100226, Taiwan

  • National University Hospital

    RECRUITING

    Singapore, 119074, Singapore

  • Pablo Tobon Uribe Hospital

    RECRUITING

    Medellín, 050034, Colombia

  • Peter MacCallum Cancer Center, State

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Polyclinic San Matteo, IRCCS

    RECRUITING

    Pavia, 27100, Italy

  • Pontifical University Of Rio Grande Do Sul (PUCRS) - St. Luke Hospital

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Porto Alegre Clinical Hospital (HCPA), Infectious Diseases / Internal Medicine

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Practice of R Moodley and MI Sarvan - Umhlanga

    RECRUITING

    Umhlanga, 4320, South Africa

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Qingyuan People's Hospital

    RECRUITING

    Qingyuan, 511518, China

  • Rambam Health Care Campus, Institute of Infectious Diseases

    RECRUITING

    Haifa, 3109601, Israel

  • Rennes University Hospital Center - Hospital Pontchaillou

    RECRUITING

    Rennes, 35000, France

  • Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Ryexo Clinical Research

    WITHDRAWN

    Pretoria, 0084, South Africa

  • Saint Luc University Hospital, Department of Internal Medicine

    RECRUITING

    Brussels, 1200, Belgium

  • Samsung Medical Center

    SUSPENDED

    Seoul, 06351, South Korea

  • Santa Marcelina Hospital

    RECRUITING

    São Paulo, São Paulo, 08270-070, Brazil

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Shamir Medical Center, Department of Infectious Diseases

    RECRUITING

    Ẕerifin, 7033001, Israel

  • Shenzhen Third People's Hospital

    RECRUITING

    Shenzhen, 518112, China

  • Singapore General Hospital

    RECRUITING

    Singapore, 169608, Singapore

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310016, China

  • Siriraj Hospital

    RECRUITING

    Bangkok, 10700, Thailand

  • Somer Clinic

    RECRUITING

    Rionegro, 54040, Colombia

  • Songklanagarind Hospital

    RECRUITING

    Hat Yai, 90110, Thailand

  • Srinagarind Hospital

    RECRUITING

    Khon Kaen, 40002, Thailand

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407219, Taiwan

  • Taipei Medical University Hospital

    RECRUITING

    Taipei, 11000, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • Tan Tock Seng Hospital

    RECRUITING

    Singapore, 308433, Singapore

  • The 1st Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, 330006, China

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, 233099, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, 510230, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Zhengzhou, 471003, China

  • The First Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, 510080, China

  • The Tel Aviv Sourasky Medical Center, Infectious Diseases Unit

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Tours Regional University Hospital Center

    RECRUITING

    Tours, 37000, France

  • Tzaneio General Hospital

    SUSPENDED

    Piraeus, 185 36, Greece

  • U.T. MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UC Davis Medical Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UCL Mont-Godinne University Hospitals

    SUSPENDED

    Yvoir, 5530, Belgium

  • UPMC Presbyterian

    RECRUITING

    Pittsburgh, Pennsylvania, 15213-2582, United States

  • University General Hospital of Heraklion

    RECRUITING

    Heraklion, 715 00, Greece

  • University Hospital Brussels

    RECRUITING

    Brussels, 1090, Belgium

  • University Hospital Cologne, Department of Internal Medicine I, Clinical Study Centre II for Infectious Diseases

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • University Hospital Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • University Hospital Giessen and Marburg GmbH

    RECRUITING

    Giessen, Hesse, 35392, Germany

  • University Hospital Graz, Department of Internal Medicine

    RECRUITING

    Graz, 1100, Austria

  • University Hospital Heidelberg, Clinic for Anesthesiology

    RECRUITING

    Heidelberg, 69120, Germany

  • University Hospital Nuestra Senora de Valme

    RECRUITING

    Seville, Andalusia, 41014, Spain

  • University Hospital Ramon y Cajal, Department of Infectious Diseases

    RECRUITING

    Madrid, Madrid, 28034, Spain

  • University Hospital Regensburg

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • University Hospital Ulm, Comprehensive Infectious Diseases Center Ulm (CIDCU)

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University Hospital Vall d'Hebron, Intensive Care Unit (ICU)

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • University Hospital Virgen Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • University Hospital of Pisa

    RECRUITING

    Pisa, 56124, Italy

  • University Hospitals Leuven, Campus Gasthuisberg, Department of Infectious Diseases

    RECRUITING

    Leuven, 3000, Belgium

  • University Medical Center "N. I. Pirogov", Burns and Plastic Surgery Clinic

    RECRUITING

    Sofia, 1606, Bulgaria

  • University Medical Center "N. I. Pirogov", Clinic of Purulent-Septic Surgery

    RECRUITING

    Sofia, 1606, Bulgaria

  • University Polyclinic Hospital of Modena

    RECRUITING

    Modena, 41124, Italy

  • University of Alabama at Birmingham School of Medicine, Department of Medicine

    RECRUITING

    Birmingham, Alabama, 35294-0006, United States

  • University of Kentucky College of Medicine

    SUSPENDED

    Lexington, Kentucky, 40506, United States

  • University of Michigan Health System (UMHS) - A. Alfred Taubman Health Care Center

    RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104-6243, United States

  • University of Pretoria / Steve Biko Academic Hospital

    SUSPENDED

    Pretoria, 0084, South Africa

  • University of Texas Health Science Center at San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Vajira Hospital

    RECRUITING

    Bangkok, 10300, Thailand

  • Victor Dupouy Hospital Center Argenteuil, Intensive Care Unit

    RECRUITING

    Argenteuil, 95107, France

  • Washington University School of Medicine, Infectious Diseases Clinical Research Unit

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College - NewYork-Presbyterian Hospital

    RECRUITING

    New York, New York, 10065, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, 610041, China

  • Westmead Hospital

    RECRUITING

    Sydney, New South Wales, 2145, Australia

  • Wuxi People's Hospital

    RECRUITING

    Wuxi, 214023, China

  • Zhejiang Provincal Hospital of Chinese Medicine

    RECRUITING

    Hangzhou, 310006, China

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, 310014, China

  • Zhongnan Hospital of Wuhan University

    RECRUITING

    Wuhan, 430071, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.