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Study comparing 7-day versus 14-day antifungal treatment for patients with uncomplicated candidemia using fluconazole, anidulafungin, or other medications

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at candidemia, which is a serious infection caused by a type of yeast called Candida that enters the bloodstream. The study will test different durations of treatment using antifungal medications, which are drugs that fight fungal infections. The medications that may be used in this study include anidulafungin, caspofungin, micafungin, amphotericin B liposome, fluconazole, and voriconazole. These medications work to eliminate the yeast infection from the blood.

The purpose of the study is to find out if treating uncomplicated candidemia, which means the infection has not spread to other parts of the body, for 7 days after the first blood test shows no more yeast is as effective as treating it for 14 days after that first clear blood test. The study will compare how many patients are alive 28 days after their first negative blood culture between the two treatment durations. Patients in the study will receive one of the antifungal medications mentioned above, and the length of treatment will depend on which group they are randomly assigned to.

During the study, patients will have blood tests to check their liver function and to confirm that the infection has cleared. The study will also track whether the infection comes back or spreads to other parts of the body. Patients will be followed for up to 45 days to monitor their recovery and check for any signs that the infection has returned. The study will also look at the costs associated with each treatment duration to understand the economic impact of the different approaches.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and enrollment

    Your eligibility for this study will be confirmed based on specific criteria. You must be at least 18 years old with a predicted life expectancy greater than 4 weeks.

    You must have a positive blood culture showing Candida (a type of yeast infection in the blood), with results available within 72 hours before joining the study.

    If you have a low white blood cell count (below 500 cells per cubic millimeter), the expected duration of this condition must be less than 7 days.

    Written consent will be obtained from you or your relatives before participation begins.

  2. Step 2

    Start of antifungal treatment

    You will receive treatment with one of several antifungal medications. The specific medication will be selected by your medical team.

    The medications that may be used include voriconazole, anidulafungin, caspofungin, amphotericin B liposome, fluconazole, or micafungin.

    These medications may be given either through a vein (intravenous) or by mouth (oral), depending on which medication is chosen.

    Treatment will continue until your first blood culture test shows no Candida (negative blood culture).

  3. Step 3

    First negative blood culture and randomization

    Once your blood culture test shows no Candida for the first time, this will be marked as Day 1.

    At this point, you will be randomly assigned to one of two treatment duration groups.

    One group will continue antifungal treatment for 7 days after the first negative blood culture.

    The other group will continue antifungal treatment for 14 days after the first negative blood culture.

    The assignment to either group will be done randomly, like flipping a coin.

  4. Step 4

    Continuation of treatment based on assigned group

    You will continue receiving the antifungal medication for either 7 or 14 days, depending on which group you were assigned to.

    The type of medication, dosage, and method of administration will remain as determined by your medical team.

    Your medical team will monitor your condition throughout this treatment period.

  5. Step 5

    Assessment at Day 14

    Approximately 14 days after your first negative blood culture (with a possible variation of 2 days), you will have an assessment.

    Blood tests will be performed to check your liver function, including measurements of ASAT, ALAT, GGT, PAL, and bilirubin levels.

    These tests help determine how your liver is functioning during and after the treatment.

  6. Step 6

    Assessment at Day 28

    Approximately 28 days after your first negative blood culture (with a possible variation of 2 days), you will have another assessment.

    Your overall health status will be evaluated, including whether the infection has spread to other parts of your body.

    Information about your survival and any complications will be recorded.

    If you are still in the hospital at this time, additional cost-effectiveness information may be collected.

  7. Step 7

    Follow-up assessment at Day 45

    Approximately 45 days after your first negative blood culture (with a possible variation of 2 days), you will have a final assessment.

    Your medical team will check whether the infection has returned (relapse) or spread to other locations in your body.

    This assessment marks the end of your participation in the study.

Who can join the trial?

7 criteria

  • You must be an adult, which means 18 years old or older
  • Your doctors must expect that you will live for more than 4 weeks
  • You must have a positive blood test showing the presence of Candida, which is a type of yeast that can cause infection in the blood
  • The results of your first positive blood test must have been obtained less than 72 hours before joining the study
  • If you have aplasia, which means your body has very low levels of white blood cells that fight infection (below 500 cells per cubic millimeter), your doctors must expect this condition to last less than 7 days
  • You must have social security coverage
  • You or your family members must provide written permission for you to participate in the study

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been specified in the available study information
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Investigated drugs

Antifungal medication for candidemia - This is a medicine used to treat candidemia, which is a serious infection caused by yeast called Candida that enters the bloodstream. The study compares two different lengths of time for taking this antifungal treatment to see which works better while keeping patients safe.

What is already known about the treatment

CANDISHORT – This is a clinical research study comparing two different treatment durations for patients with uncomplicated candidemia, which is a bloodstream infection caused by Candida fungi. The trial investigates whether treating patients for 7 days after their blood tests show no more infection is as effective as the standard 14-day treatment period, measuring success by patient survival rates at 28 days. This study aims to potentially shorten treatment time while maintaining the same level of safety and effectiveness, which could reduce medication side effects and healthcare costs for patients with this type of fungal blood infection.

Investigated diseases

Uncomplicated Candidemia – Candidemia is a bloodstream infection caused by Candida fungi, which are types of yeast that normally live on the skin and inside the body. When these fungi enter the bloodstream, they can multiply and spread throughout the body. Uncomplicated candidemia refers to cases where the infection is limited to the blood and has not spread to other organs or tissues. Patients typically develop fever and chills that do not improve with antibiotics. The condition occurs most often in people who are hospitalized, especially those with weakened immune systems or medical devices like catheters. The infection progresses as the Candida organisms continue to circulate in the bloodstream until appropriate antifungal treatment is administered.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514244-81-00Protocol codeAPHP230824Estimated enrolment399 patientsSponsorAssistance Publique Hopitaux De Paris

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