Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT03468803
Eligibility Criteria:
Inclusion Criteria:
* Elective open abdominal surgery involving the small and/or large colon and with surgical sectioning of intestinal mucosa
* Signed informed consent
Exclusion Criteria:
* Ongoing antifungal therapy for treatment of active fungal infection or antifungal therapy within 4 weeks prior to inclusion
* Antibiotic therapy other than optional single shot surgical prophylaxis as clinically indicated
* Ongoing Enterococcus sp. bacteremia or treatment of Enterococcus sp. bacteremia within 4 weeks prior to inclusion
* Clinical or radiological or laboratory evidence of current infectious disease (i.e. temperature \>38°C, elevated C-reactive protein (CRP) \>5mg/dl, leukocytosis \>11400/μl, elevated neutrophiles \>78%) as assessed by the treating physician
* Immunoglobulin, blood or blood products (i.e. thrombocytes, fresh frozen plasma) administration within 4 weeks prior to inclusion
* Abdominal surgery (laparoscopic or open) or other major surgeries (e.g. aortocoronary bypass) within 4 weeks prior to inclusion
* Subsequent invasive candidiasis (defined according to proposed European Organization for Research and Treatment of Cancer Mycoses study group \[EORTC/MSG\] definitions of fungal infections in ICU) or other complicating infectious disease after surgery within the 5 day observation time frame
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03468803
Study Brief:
Protocol Section:
NCT03468803