Not yet recruiting

Shortening treatment duration in adults with uncomplicated candidemia: caspofungin acetate versus saline and sodium lactate placebo

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

The study looks at patients with Candidemia, a bloodstream infection caused by yeast‑like fungi called Candida. The experimental treatment is caspofungin acetate, given by infusion (a fluid delivered directly into a vein). Some participants receive a harmless fluid called placebo in the same way.

The aim is to find out whether a shorter course of the antifungal medication works as well as the usual 14‑day regimen after the infection has cleared, meaning it is not worse (non‑inferior). Participants receive the assigned IV medication for a limited period and then continue to be observed for about a month.

During the follow‑up period, doctors check for any return of the infection, overall health status, and any side effects from the drug. Simple questionnaires are used to capture quality of life and physical functioning, and routine tests are performed to confirm that the fungus has been eliminated.

The research process

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

Step 1
Enrollment and consent
After agreeing to participate, you are entered into the trial and receive information about the study procedures.
Your baseline health status is recorded before any study medication is given.
Step 2
Randomization
You are assigned, without knowing which group you are in, to receive either the test medication caspofungin acetate or a placebo.
The assignment is made by a computer system to ensure fairness.
Step 3
First infusion
On the first day you receive an intravenous infusion, which means the medicine is delivered through a vein.
If you are in the test group, the infusion contains caspofungin acetate at a dose of 70 mg.
If you are in the placebo group, the infusion contains either sodium lactate 1000 ml or saline 1000 ml, both of which do not contain active antifungal drug.
Step 4
Daily infusions
The same type of infusion is given once each day.
Treatment continues until the predetermined end of therapy, which may be 7 days (short course) or 14 days (standard course) after the blood culture shows that candidemia has cleared.
The exact length of treatment is decided by the study protocol based on your response.
Step 5
Clinical assessment at day 7
On day 7 you undergo a clinical evaluation to determine whether the infection has been cleared.
The assessment includes physical examination, blood tests for fungal presence, and, if needed, imaging studies.
The results help decide if the short‑course treatment can be completed.
Step 6
End of study treatment and final assessment
When the assigned treatment period ends (either after 7 or 14 days), a final evaluation is performed.
Clinical cure, radiological cure, and mycological eradication are documented.
The same procedures as on day 7 are repeated to confirm that the infection is resolved.
Step 7
Follow‑up at day 37
30 days after the end of treatment, on day 37, you return for a follow‑up visit.
The visit assesses any recurrence of candidemia, overall health status, and any adverse events that may be related to the study drug.
Patient‑reported outcome measures, such as quality of life and physical functioning, are collected using standardized questionnaires.

Who can join the trial?

10 criteria

Be at least 18 years old on the day you sign the study paperwork.
Provide written informed consent, meaning you agree to join after understanding the study, or have a legally authorized representative do so.
If you are a woman who could become pregnant, you must agree to use a very effective form of contraception (such as sterilization, hormonal birth control, an IUD, or a vasectomized partner) or choose not to have sex for the whole study period and for 30 days after the last dose.
Be receiving the antifungal medicine caspofungin for a confirmed case of candidemia, which means a Candida fungus was found in your blood by a blood culture test.
Have an uncomplicated infection, which means:
- You have already taken caspofungin for 7 straight days before the study starts, and the blood test on day ‑7 showed no Candida, with no positive tests from day ‑6 to day ‑1.
- You will continue the same medicine for another 7 days during the study.
- Less than 120 hours passed between the first positive blood culture and the first negative one.
- All sources of the infection must have been controlled, which includes:
  - Removing or replacing any central line (such as a central venous catheter, PICC line, or implanted port) within 48 hours after starting caspofungin.
  - Removing or replacing any implanted heart device, ventricular assist device, ECMO machine, or other foreign body in the blood vessels after 48 hours of starting treatment.
  - Successfully treating any intra‑abdominal Candida infection (like an abscess or peritonitis) within 5 days of starting the medicine, with or without surgery.

Who cannot join the trial?

19 criteria

You must not have any Candida-positive blood culture (a test that shows Candida fungus in the blood) taken in the week before the study starts (Days -7 to -1).
Your absolute neutrophil count (a measure of a type of white blood cell that fights infection) cannot be below 0.5 G/L at any time while you are in the study.
You cannot have a Child‑Pugh score greater than 9, which is a calculation used to assess how badly the liver is damaged.
Pregnant women and mothers who are breastfeeding are not allowed to join; a negative pregnancy blood test is required for all women who could become pregnant.
People who use illegal drugs by injection (intravenous illicit drug use) cannot participate.
If you have taken an investigational drug (a drug that is not yet approved) within 30 days before the first dose of the study medication, or within five half‑lives of that drug (the time it takes for half of the drug to leave the body), you are excluded.
Anyone who has already taken part in this same trial before is not eligible.
People who have a work or dependent relationship with the study sponsor or investigators cannot join.
If you have complicated candidemia (a serious Candida blood infection) you are excluded. This includes:
- Having had candidemia in the past three months.
- Having Candida infection in deep body areas outside the abdomen, such as the brain or spinal cord (central nervous system infection), eye infections (chorioretinitis or endophthalmitis), infections of blood vessels (intravascular infection), heart valve infection (endocarditis), kidney abscess, bone infection (osteomyelitis), or joint infection.
- Having Candida infection inside the abdomen in the past three months, unless it was the very first episode and was successfully treated within five days of the current candidemia diagnosis.
- Having a Candida strain that is resistant to the drug class called echinocandins.
- People with a blood cancer (hematological malignancy) that is not in remission (meaning the disease is still active) cannot join.
- If you have had an allogeneic hematopoietic stem‑cell transplant (a bone‑marrow transplant from a donor) within the last year, you are excluded.
- Those with a severe form of graft‑versus‑host disease (grade III or IV), a complication that can occur after a transplant, cannot take part.
- If you are allergic (hypersensitive) to the study drug caspofungin or any of its inactive ingredients (excipients), you must not enroll.
- People who are taking high‑dose steroids (glucocorticosteroids) at a level of 0.3 mg/kg or more of prednisone‑equivalent per day, and plan to take them for more than three weeks, are not eligible.
- You cannot be taking any of the following medicines while in the study: rifampin/rifampicin, phenytoin, carbamazepine, efavirenz, or nevirapine.
- Your absolute neutrophil count must not be below 0.5 G/L when you are screened for the trial.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Carl Von Ossietzky Universitaet Oldenburg
Verified
Oldenburg In Holstein, Germany
Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Goethe University Frankfurt
Verified
Frankfurt, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

caspofungin acetate is an antifungal medicine given through an IV infusion. In this study it is the drug being tested to see if a shorter course of treatment can safely cure uncomplicated bloodstream infections caused by Candida (candidemia). Participants receive the medication after their infection is confirmed, and researchers compare how well a reduced treatment length works compared with the standard 14‑day regimen.

What is already known about the treatment

Sodium Lactate
It is administered by IV infusion, typically 1000 ml, and in this study acts as a placebo; sodium lactate is an established electrolyte solution that is widely used in hospitals. It is mainly used to help correct acid‑base imbalances and to provide sodium and lactate when fluids are needed. At the molecular level the lactate is metabolized to bicarbonate, which helps raise blood pH, and it is classified as an electrolyte and buffering solution.
Saline
It is given by IV infusion, usually 1000 ml, and serves as a placebo in the trial; normal saline is a standard medical fluid that has been used for many years. Its primary use is to replace lost body fluids and maintain electrolyte balance. The solution supplies sodium and chloride ions that expand blood volume and restore normal fluid levels, and it is classified as an isotonic crystalloid solution.
Caspofungin Acetate
It is delivered by IV infusion at a dose of 70 mg and is the active test drug in the study; caspofungin is an approved antifungal medication with extensive documentation in medical literature. It is used to treat serious Candida infections, especially bloodstream infections (candidemia). The drug works by blocking the enzyme that makes β‑1,3‑D‑glucan, a key component of the fungal cell wall, which weakens the wall and kills the fungus, and it belongs to the echinocandin class of antifungal agents.

Investigated diseases

Candidemia - Candidemia is a bloodstream infection caused by the yeast Candida. It begins when the fungus enters the blood, often from a catheter or another infection site. The yeast can travel to other organs, leading to a wider spread of infection. Common signs include fever and chills, though the infection may be silent at first. Over time, the fungus may multiply and involve organs such as the kidneys, eyes, or brain. The condition can persist until the yeast is cleared from the bloodstream.