A ß-d-glucan guided antifungal stewardship strategy for the management of patients with severe abdominal sepsis. A multicenter interventional explorative study with a pharmadynamic/pharmachokinetic substudy entitled: A Pilot substudy of Liposomal Amphotericin B Pharmacodynamics in Patients with Abdominal Sepsis” conducted only in the coordinating center

Phase 1

Active, not recruiting

• Conditions: Patients with severe sepsis or septic shock; MedDRA version: 23.1Level: PTClassification code 10066593Term: Post procedural sepsisSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.0Level: PTClassification code 10058040Term: Abdominal sepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2016-002335-14-IT
• Lead Sponsor: AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-04
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion criteria

1.All adult (= 18 years) patients
2.Patients with a severe surgical abdominal disease (SAD) defined as post-operative peritonitis, recurrent gastrointestinal perforation, post-operative hepatobiliary and pancreatic disorders, intra-abdominal abscess and anastomotic leak
3.Patients with severe sepsis or septic shock;
4.Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Exclusion criteria

1.Patients with documented history of hypersensitivity or allergic reaction to liposomial amphotericin B
2.Pregnancy, lactation or patients at risk for pregnancy: premenopausal or postmenopausal woman within 12 months of last menses without negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control). Diagnosis of pregnancy will be done using quantitative blood ß-HCG test.
3.Neutropenia > grade 2 defined as absolute neutrophils count = 1000/mmc
4.Concomitant treatment with cyclosporine, aminoglycosides and pentamidine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified