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    Clinical Trial Results:
    A β-d-glucan guided antifungal stewardship strategy for the management of patients with severe abdominal sepsis. A monocentric interventional explorative study with a pharmacodynamic/pharmacokinetic substudy entitled: “A Pilot Substudy of Liposomal Amphotericin B Pharmacodynamics in Patients with Abdominal Sepsis”

    Summary
    EudraCT number
    		 2016-002335-14
    Trial protocol
    		 IT  
    Global end of trial date
    11 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2025
    First version publication date
    09 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LAMBDA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 LAMBDA: LAMBDA
    Sponsors
    Sponsor organisation name
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Sponsor organisation address
    Via Albertoni 15, Bologna, Italy, 40138
    Public contact
    Prof. Pierluigi Viale, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Infectious Diseases Unit, +39 0512143595, pierluigi.viale@unibo.it
    Scientific contact
    Prof. Pierluigi Viale, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Infectious Diseases Unit, +39 0512143595, pierluigi.viale@unibo.it
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of pre-emptive therapy with Liposomal Amphotericin B (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 invasive candidiasis (IC)//intra-abdominal candidiasis (IAC)
    Protection of trial subjects
    The protection of clinical trial subjects is consistent with the principles set out in the Declaration of Helsinki
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Nov 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    20
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult patients (≥ 18 years) 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, and with severe sepsis or septic shock

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Liposomal Amphotericin B (Ambisome)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A loading dose of 5 mg/kg of L-AmB was administered on day 0. No antifungal therapy was given on days 1 and 2. On day 3, the decision to continue antifungal treatment at the standard dosage (3 mg/kg) was based on baseline serum 1,3-β-d-glucan (BG) levels (measured on day 0) and clinical criteria as follows: If baseline BG was negative (<80 pg/mL) and the patient was clinically stable, antifungal therapy was discontinued. If invasive candidiasis (IC) or intra- abdominal candidiasis (IAC) was confirmed by culture results, antifungal treatment continued at a dosage of 3 mg/kg every 24 hours for 7–14 days, as determined by the attending physician. If baseline BG was significantly positive (>200 pg/mL) or IC/IAC was confirmed by culture results, antifungal treatment was continued for 7–14 days at the attending physician’s discretion. If baseline BG was between 80 and 200 pg/mL, antifungal treatment continued at the standard dosage.

    Number of subjects in period 1
    		Overall trial
    Started
    40
    Completed
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 20 20
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 65 (49 to 76) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 15 15
    Baseline condition
    Units: Subjects
        Septic shock
    		 5 5
        Non Septic shock
    		 35 35
    BDG baseline values
    Units: Subjects
        Positive baseline BDG
    		 15 15
        Negative baseline BDG
    		 25 25
    L-AmB confirmed after first dose
    Units: Subjects
        L-AmB confirmed after first dose
    		 14 14
        L-AmB not confirmed after first dose
    		 26 26
    Comorbidities of enrolled patients at baseline (Charlson comorbidity index)
    Units: Points
        median (inter-quartile range (Q1-Q3))
    		 3 (0 to 4) -

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    Tolerability of pulse high dose L-AmB as pre-emptive therapy in patients at high risk for intra-abdominal candidiasis
    End point type
    Primary
    End point timeframe
    Overall trial
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Since the primary endpoint focuses on the safety of the investigational product, no statistical analyses were conducted; instead, the frequency of adverse events in the enrolled population was reported.
    End point values
    		 Overall trial
    Number of subjects analysed
    40
    Units: N° subjects dead
    6
    No statistical analyses for this end point

    Secondary: Incidence of invasive candidiasis

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    End point title
    		 Incidence of invasive candidiasis
    End point description
    Number of patients with confirmed invasive intra-abdominal candidiasis
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 Overall trial
    Number of subjects analysed
    40
    Units: N° subjects with confirmed invasive IAC
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: During the LAMBDA trial, six serious adverse events (SAE) and no serious adverse reactions (SARs) were reported to the Sponsor. All reported SAEs had a “fatal” outcome and no one of these was considered to be related to the investigational product. Therefore, no actions were taken for safety reasons, throughout the LAMBDA study.
    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 40 (15.00%)
         number of deaths (all causes)
    6
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Haemorrhage
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Myocarditis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Infections and infestations
    Septic shock
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Aug 2021
    Change from a multicenter study to a single-center study as the activation of other participating centers was never implemented. Possibility to obtain informed consent to participate in the study/sub-study after the decision to include the subject in the clinical trial in emergency situations, in accordance with Article 35 of EU Regulation No. 536/2014, "Clinical trials in emergency situations". Study duration modification. An addendum was added to the protocol listing the expected Serious Adverse Events (SAEs) for the disease/population under study, for which expedited reporting within 24 hours is deemed unnecessary.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37838147
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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