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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT01122368
Eligibility Criteria:
Inclusion Criteria:
* Intra-abdominal infection requiring surgery and Intensive Care Unit stay
* If Community Acquired Intra-Abdominal Infection, at least 72 hours (but not more than 120 hours) of Intensive Care Unit stay, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
* If Nosocomial Intra-Abdominal Infection, duration of Intensive Care Unit stay ≤ 48 hours, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
* Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study
Exclusion Criteria:
* Acute pancreatitis
* Neutropenia (ANC \<1,000/mm3) at the time of randomization
* Infected intra-peritoneal dialysis
* Patients undergoing solid organ transplantation
* Documented invasive candidiasis at the time of randomization
* Expected survival \< 48 hours
* Any systemically active anti-fungal within 14 days prior to administration of the study drug
* Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients
* Currently receiving and/or has taken an investigational drug within 28 days prior to randomization
* Pregnant woman or breast-feeding mother
* 'Do Not Resuscitate' order
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01122368
Study Brief:
Protocol Section:
NCT01122368