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

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 - LAMBDA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002335-14-IT

Enrollment

Registered

2020-11-04

Start date

2018-12-05

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with severe sepsis or septic shock MedDRA version: 23.1 Level: PT Classification code 10066593 Term: Post procedural sepsis System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10058040 Term: Abdominal sepsis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: AMBISOME - 50 MG POLVERE PER SOLUZIONE PER INFUSIONE 10 FLACONCINI Product Name: AmBisome Product Code: [AmBisome] Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: With this study we would evaluate the safety of pre-emptive therapy with LamB 5 mg/kg in the first 24h of treatment followed by LamB 3 mg/kg starting from the third day in patients with predefined high risk for IC/IAC.;Secondary Objective: 1.To evaluate the cost-effectiveness of the use of BG in the management of antifungal therapy in patients with a severe surgical abdominal disease and severe sepsis or septic shock. 2.To assess the accuracy of BG for diagnosing IC/IAC in patients with severe abdominal surgical disease and severe sepsis or septic shock. 3.To investigate the outcome in terms of time to clinical stability, length of ICU and/or hospital stay, and rate of in-hospital mortality of the overall study cohort patients and in patients with IAC;Primary end point(s): Primary Endpoint: Safety will be assessed according to the incidence of grade 3 to 4 adverse events (AEs) based on the Common Toxicity Criteria (CTC) classification, reported as definitely, possibly, or probably related to the study drug. The incidence of adverse events will be investigated from the initiation of the study drug until to 30 days after the study drug discontinuation. An iterim analysis will be performed after the enrollment of 19 patients. Only a rate of 10% of AEs will be acceptable (see sample size and iterim analysis section);Timepoint(s) of evaluation of this end point: 2 months (maximum 28 days of treatment and 30 days of follow-up after the end of treatment)	—

Measure

Time frame

Main Objective: With this study we would evaluate the safety of pre-emptive therapy with LamB 5 mg/kg in the first 24h of treatment followed by LamB 3 mg/kg starting from the third day in patients with predefined high risk for IC/IAC.;Secondary Objective: 1.To evaluate the cost-effectiveness of the use of BG in the management of antifungal therapy in patients with a severe surgical abdominal disease and severe sepsis or septic shock. 2.To assess the accuracy of BG for diagnosing IC/IAC in patients with severe abdominal surgical disease and severe sepsis or septic shock. 3.To investigate the outcome in terms of time to clinical stability, length of ICU and/or hospital stay, and rate of in-hospital mortality of the overall study cohort patients and in patients with IAC;Primary end point(s): Primary Endpoint: Safety will be assessed according to the incidence of grade 3 to 4 adverse events (AEs) based on the Common Toxicity Criteria (CTC) classification, reported as definitely, possibly, or probably related to the study drug. The incidence of adverse events will be investigated from the initiation of the study drug until to 30 days after the study drug discontinuation. An iterim analysis will be performed after the enrollment of 19 patients. Only a rate of 10% of AEs will be acceptable (see sample size and iterim analysis section);Timepoint(s) of evaluation of this end point: 2 months (maximum 28 days of treatment and 30 days of follow-up after the end of treatment)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of BG for diagnosing IC/IAC, established according to clinical and microbiological criteria, will be analyzed. 2. The time from severe sepsis or septic shock onset to clinical stability, the days of ICU and/or hospital stay and in-hospital all-cause mortality will be evaluated for all the enrolled patients and for patients with confirmed IC/IAC;Timepoint(s) of evaluation of this end point: 2 months (maximum 28 days of treatment and 30 days of follow-up after the end of treatment)	—

Measure

Time frame

Secondary end point(s): 1. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of BG for diagnosing IC/IAC, established according to clinical and microbiological criteria, will be analyzed. 2. The time from severe sepsis or septic shock onset to clinical stability, the days of ICU and/or hospital stay and in-hospital all-cause mortality will be evaluated for all the enrolled patients and for patients with confirmed IC/IAC;Timepoint(s) of evaluation of this end point: 2 months (maximum 28 days of treatment and 30 days of follow-up after the end of treatment)

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Countries

Italy

Contacts

Public ContactU.O. Malattie Infattive

AOU di Bologna

pierluigi.viale@unibo.it0512143353

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026