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Compares treatment options for ICU Yeast Intra-abdominal Infection
Official title Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
ClinicalTrials.gov ID: NCT03580733
What this study is testing
What is caspofungin antifungal therapy?
caspofungin antifungal therapy is an investigational medicine, being studied as a potential treatment for icu yeast intra-abdominal infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The incidence of intra-abdominal candidiasis is increasing, and it is now the leading indication for antifungal therapy, ahead of candidemia. Prospective randomized trials of antifungal therapy have almost exclusively concerned patients with candidemia and did not include patients with intra-abdominal infections.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years old
- Covered by national health insurance
- Admitted to ICU after surgery for intra-abdominal infection :
- With suspected intra-abdominal candidiasis defined by a Peritonitis score ≥ 3(1)
- Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected...
You likely can't join if
- Allergy to caspofungin
- Life expectancy ≤ 48h
- Expected withdrawal of treatment
- Radiological drainage without surgery
- Severe hepatic impairment (Child-Pugh C score)
- Pregnant or lactating women
See the full eligibility criteria
- Age ≥ 18 years old
- Covered by national health insurance
- Admitted to ICU after surgery for intra-abdominal infection :
- With suspected intra-abdominal candidiasis defined by a Peritonitis score ≥ 3(1)
- Or with documented intra-abdominal candidiasis defined by positive direct examination or positive culture of peritoneal fluid collected intraoperatively.
- With written and signed informed consent
- Allergy to caspofungin
- Life expectancy ≤ 48h
- Expected withdrawal of treatment
- Radiological drainage without surgery
- Severe hepatic impairment (Child-Pugh C score)
- Pregnant or lactating women
- Immunodepression (treatment including long-term corticosteroids, anti-TNF or disease including transplant patients)
- Infected acute pancreatitis
- Ascites fluid infection
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.