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

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What is this study about?

This clinical trial is focused on studying the treatment of two serious fungal infections: candidemia and invasive candidiasis. These infections are caused by a type of yeast called Candida, which can enter the bloodstream and spread to other parts of the body, leading to severe health issues. The study will compare the effectiveness and safety of a new treatment called fosmanogepix, which is given first through an IV (intravenous) and then as an oral medication, against a standard treatment that starts with an IV of caspofungin followed by oral fluconazole.

The purpose of the study is to evaluate how well the new treatment works in adults with these infections. Participants will receive either the new treatment or the standard treatment, and some may receive a placebo. The study will monitor participants over a period to see how their infections respond to the treatments. This includes checking for improvements in symptoms and any side effects that may occur. The study aims to provide valuable information on whether the new treatment is a better option for managing these infections.

Participants will be closely monitored by healthcare professionals throughout the study. The study will involve regular check-ups and tests to track the progress of the treatment and ensure the safety of all participants. The results of this study could help improve treatment options for people suffering from these serious fungal infections in the future.

1 joining the study

Upon joining the study, you will be asked to provide signed informed consent. This indicates that you understand the purpose and procedures required for the study and are willing to participate.

2 initial assessment

You will undergo an initial assessment to confirm the diagnosis of candidemia and/or invasive candidiasis. This includes tests to detect the presence of Candida in your blood or from a sterile site.

The assessment will also check for symptoms such as fever, low body temperature, low blood pressure, rapid breathing, rapid heart rate, and local signs of infection.

3 randomization

You will be randomly assigned to one of two treatment groups. One group will receive IV fosmanogepix followed by oral fosmanogepix, and the other group will receive IV caspofungin followed by oral fluconazole.

4 treatment phase

During the treatment phase, you will receive the assigned medication. The initial phase involves intravenous (IV) administration, followed by oral medication.

The duration and dosage of the medication will be determined by the study protocol and your healthcare provider.

5 monitoring and follow-up

Throughout the study, your health will be closely monitored. This includes regular blood tests, clinical assessments, and possibly other diagnostic tests.

You will be evaluated for treatment success and any side effects. The study will also track the time it takes for your blood cultures to become negative.

6 end of study treatment

At the end of the study treatment (EOST), your overall response to the treatment will be assessed by an independent committee.

You will continue to be monitored for a period after the treatment to evaluate long-term outcomes and any delayed side effects.

Who Can Join the Study?

  • Patients must be 18 years or older at the time of screening. If the country requires a higher age for consent, that age applies.
  • Patients must provide signed informed consent, which means they understand the study’s purpose and procedures and agree to participate.
  • Patients must have a diagnosis of candidemia and/or invasive candidiasis within the last 96 hours (4 days) before being randomly assigned to a treatment group. This means:
    • There is a positive test for yeast or Candida in the blood or from a normally sterile area of the body.
    • A positive result from a rapid diagnostic test for Candida from a blood sample.
    • Presence of clinical signs like fever (high body temperature), hypothermia (low body temperature), hypotension (low blood pressure), tachypnea (fast breathing), tachycardia (fast heart rate), or local signs of infection such as swelling or redness.
  • The patient’s condition must allow for infection source control measures, such as removing any pre-existing catheters or devices if needed.

Who Cannot Join the Study?

  • Patients who have a known allergy or severe reaction to the study drugs cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with a history of certain serious medical conditions that might interfere with the study cannot join.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients who have received certain medications that might interfere with the study drugs are excluded.
  • Patients with a history of drug or alcohol abuse that might affect their ability to follow the study procedures cannot participate.
  • Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medical University Of Vienna Vienna Austria
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria
Katholieke Universiteit te Leuven Leuven Belgium
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Azienda Sanitaria Universitaria Giuliano Isontina Trieste Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hospital Del Mar Barcelona Spain
University General Hospital Of Heraklion Heraklion Greece
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Centre Hospitalier Victor Dupouy Argenteuil France
Evangelismos S.A. Athens Greece
Universitaetsklinikum Regensburg AöR Regensburg Germany
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
IRCCS Ospedale Policlinico San Martino Genoa Italy
Universita’ Di Pisa Pisa Italy
Klinik Favoriten Vienna Austria
Jessa Ziekenhuis Hasselt Belgium
Hospital Universitario Virgen De Valme Sevilla Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nantes Nantes France
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Geniko Nosokomeio Peiraia Tzaneio Piraeus Greece
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Vrije Universiteit Brussel Jette Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Cipadgedw Ulacdhecdbgiel Sgcaxipun Woluwe-Saint-Lambert Belgium
Aicwucl Otfiyzvgazp Ukoffdfkvdjjv Saliug Siena Italy
Lilta Gzhytsc Hvibagoy Oy Auxsyi Athens Greece
Ufmnijukvn Hlnoyiap Cydqcif Cologne Germany
Audwnkijwf Pynnaizj Hvrcssgi Dj Mieoyeehd Marseille France
Cpmlft Hmdpknayujk Rebycyvl Ugmvgkqoeoter Dt Tjexu Tours France
Gxnocd Uygtxocndl Fmavmtywv Frankfurt Germany
Jfiyvtuc Khghtp Ucwscpfjdj Linz Austria
Hxycrtxp Vimr dwifktlk Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
07.11.2024
Belgium Belgium
Recruiting
07.11.2024
Bulgaria Bulgaria
Recruiting
07.11.2024
France France
Recruiting
07.11.2024
Germany Germany
Recruiting
07.11.2024
Greece Greece
Recruiting
07.11.2024
Italy Italy
Recruiting
07.11.2024
Spain Spain
Recruiting
07.11.2024

Trial locations

Fosmanogepix is a medication being tested in this clinical trial. It is given first through an IV, which means it is delivered directly into your bloodstream through a vein. After the initial IV treatment, it is taken by mouth as a pill. This medication is being studied to see how well it works in treating infections caused by a type of fungus, specifically in conditions known as candidemia and invasive candidiasis. These are serious infections that can occur in the blood or other parts of the body.

Caspofungin is a medication used as a standard treatment for fungal infections. In this trial, it is given through an IV, which means it is administered directly into the bloodstream. Caspofungin is used to treat serious fungal infections, and in this study, it serves as a comparison to see how well the new medication, fosmanogepix, works.

Fluconazole is another medication used in this trial as part of the standard treatment for fungal infections. After the initial treatment with caspofungin, fluconazole is taken by mouth as a pill. It is commonly used to treat and prevent various fungal infections, and in this study, it helps to compare the effectiveness of the new treatment being tested.

Invasive candidiasis – Invasive candidiasis is a severe fungal infection caused by Candida species that enter the bloodstream and spread throughout the body. It can affect various organs, including the heart, brain, eyes, bones, and other tissues. The disease often begins with a fever and chills that do not improve with antibiotic treatment. As the infection progresses, it can lead to organ dysfunction and other systemic symptoms. The condition is more common in individuals with weakened immune systems or those with medical devices like catheters. It requires prompt medical attention to prevent further complications.

Candidemia – Candidemia is a bloodstream infection caused by Candida species, a type of yeast. It is the most common form of invasive candidiasis and can lead to serious health issues if not addressed. The infection typically presents with symptoms such as fever, chills, and fatigue, which may persist despite antibiotic treatment. As the yeast circulates in the bloodstream, it can spread to other parts of the body, potentially affecting organs and tissues. Candidemia is often associated with hospital settings, particularly in patients with compromised immune systems or those undergoing invasive procedures. Early detection and management are crucial to control the spread of the infection.

Trial ID:
2022-500455-23-00
Protocol code:
FMGX-CS-301
NCT ID:
NCT05421858
Trial Phase:
Therapeutic confirmatory (Phase III)

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