A B-D-Glucan Driven Antifungal Stewardship Approach for Invasive Candidiasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-06-10

Brief Summary

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This is a multicenter, prospective, open-label, randomized trial. Patients with severe abdominal condition developing severe sepsis or septic shock and receiving broad spectrum antibiotic and antifungal treatment will be randomized (1:1) to:

1. discontinue antifungal treatment based on negative (\<80 pg/ml) result of 1,3 beta-d-glucan performed on day 0,3,6 and 10
2. continue antifungal treatment according with attending physician's decision.

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Detailed Description

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Primary objective:

Our objective is to establish whether a strategy based on beta-d-glucan (BG) assessment could achieve reduced antifungal consumption in patients with severe abdominal condition developing severe sepsis and septic shock without any impact on the outcome Secondary objectives i) Assess the accuracy of BG in the diagnosis of invasive candidiasis (IC) in in critically ill patients with a severe abdominal condition who develop severe sepsis or septic shock.

ii) Describe the changes over the time of BG value according with colonization status, infection or none the aforementioned events.

Material and Methods Study design: a multicenter, open label, randomized trial Population: all the patients with a severe abdominal condition who develop a severe sepsis or septic shock.

1. Inclusion Criteria:

1. adult (≥ 18 year) patients;
2. signed informed consent before surgical procedure;
3. severe sepsis or septic shock;
4. at least one of the following conditions: i) post-operative peritonitis, ii) recurrent gastrointestinal perforation, iii) post-operative hepatobiliary and/or pancreatic disorders including necrotizing pancreatitis, iv) post-operative intra-abdominal abscess, and v) anastomotic leak.
2. Exclusion criteria a. diagnosis of candidiasis before the enrollment b. exposure in the past 30 days to any antifungal treatment or diagnosis of invasive fungal infection; c. pregnancy or lactation; d. history of allergy to any of the antifungal drugs; e. major immunosuppression conditions including: i. neutropenia (\<0.5 × 109 neutrophils/L \[\<500 neutrophils/mm3\] for \>10 days), ii. receipt of an allogeneic stem cell transplant or solid organ transplantation, iii. inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency), iv. HIV infection with lymphocyte T CD4+ cell count \< 200/mmc. f. patients with poor prognosis or unable to sign informed consent.

Procedures Pre-randomization procedures

At the time of patient enrollment (within 24 h from onset of severe sepsis/septic shock), a standardized diagnostic work-up must be performed including at least:

i) two sets of blood cultures; ii) 5 surveillance cultures (rectal swab, urine culture, pharyngeal swab, axillary swab, groin swab).

iii) in case of re-intervention or percutaneous drainage: Gram stain and culture of intra-abdominal samples; iv) serum BG determination. Antibiotic and antifungal empirical therapy should be started immediately after collection of microbiological samples according with a predefined standard of care (see appendix 1). Once completed this procedures patients will proceed to randomization.

Randomization Patient eligible for the study after the beginning of antifungal therapy will be randomized 1:1 to receive (Group A) a BG driven de-escalation strategy or (Group B) a course of antifungal treatment based on the care provider's decision.

In both groups, if cultures yield invasive candidiasis (see below) the patient will be managed in according with guidelines and excluded from the per-protocol analysis.

In both groups, BG determination will be repeated at day +3, +6 and +10 after starting antifungal therapy.

Randomization will be carried out providing closed envelopes to the participating centers immediately before the study onset.

Conditions

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Invasive Candidiases Abdominal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Caregivers

Care provider will be blinded to result of BG in patients enrolled in the standard of care arm

Study Groups

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De-escalation

In this group, investigators will manage the antifungal therapy according to the BG levels as follows:

1. antifungal therapy will be stopped immediately after the BG response in case of serum BG \<80 pg/ml in presence of clinical stability (CS);
2. antifungal therapy will be continued until further BG determination, both for BG levels between 80-200 pg/ml and for BG \<80 pg/ml in patients without CS. In these cases, if the following BG value is \<80 pg/ml antifungal therapy will be stopped independently from the CS achievement.
3. antifungal therapy will be continued until day 10 for BG levels \>200 pg/ml

Group Type EXPERIMENTAL

De-escalation

Intervention Type DIAGNOSTIC_TEST

Antifungal therapy will be stopped according with BG results

Standard of care

In this group antifungal treatment will be continued until clinician's decision.

Investigators will be blinded to the BG levels of patients enrolled in this arm, The BG results will be faxed directly to the coordinating center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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De-escalation

Antifungal therapy will be stopped according with BG results

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* a. adult (≥ 18 year) patients; b. signed informed consent before surgical procedure; c. severe sepsis or septic shock; d. at least one of the following conditions: i) post-operative peritonitis, ii) recurrent gastrointestinal perforation, iii) post-operative hepatobiliary and/or pancreatic disorders including necrotizing pancreatitis, iv) post-operative intra-abdominal abscess, and v) anastomotic leak.

Exclusion Criteria

* a. diagnosis of candidiasis before the enrollment b. exposure in the past 30 days to any antifungal treatment or diagnosis of invasive fungal infection; c. pregnancy or lactation; d. history of allergy to any of the antifungal drugs; e. major immunosuppression conditions including: i. neutropenia (\<0.5 × 109 neutrophils/L \[\<500 neutrophils/mm3\] for \>10 days), ii. receipt of an allogeneic stem cell transplant or solid organ transplantation, iii. inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency), iv. HIV infection with lymphocyte T CD4+ cell count \< 200/mmc. f. patients with poor prognosis or unable to sign informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No