Comparing caspofungin to placebo for treating yeast infections in ICU patients
Prospective Multicentre Randomized Double-blind Study Comparing Caspofungin to Placebo for the Treatment of ICU Intra-abdominal Candidiasis
This study is testing if a medication called caspofungin can help ICU patients with yeast infections in their abdomen feel better compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 448 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT03580733 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of caspofungin antifungal therapy compared to a placebo in patients with intra-abdominal candidiasis in the ICU. Given the rising incidence of this condition, which is associated with significant morbidity and mortality, the study seeks to provide evidence for a treatment approach that has not been extensively tested in this specific patient population. Participants will be randomly assigned to receive either caspofungin or a placebo, and the primary outcome will be the failure rate of treatment. The study will include patients who are at least 18 years old and have been admitted to the ICU after surgery for suspected or documented intra-abdominal candidiasis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU after surgery with suspected or confirmed intra-abdominal candidiasis.
Not a fit: Patients with severe hepatic impairment, those expected to withdraw treatment, or those with certain infections or conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for ICU patients suffering from intra-abdominal candidiasis.
How similar studies have performed: While there have been many studies on antifungal therapies for candidemia, this specific approach for intra-abdominal candidiasis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Hervé Dupont, PD
- Email: dupont.herve@chu-amiens.fr
- Phone: 33 322 087 979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.