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    Clinical Trial Results:
    Use of a respiratory multiplex PCR and procalcitonin to reduce antibiotic exposure in patients with severe confirmed COVID-19 pneumonia : a multicenter, parallel-group, open-label, randomized controlled trial

    Summary
    EudraCT number
    2020-001324-33
    Trial protocol
    FR  
    Global end of trial date
    14 Apr 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Jun 2022
    First version publication date
    26 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    APHP200392
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04334850
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    Sponsor organisation address
    4 Avenue Victoria, Paris, France, 75004
    Public contact
    Hôpital Tenon, AP-HP, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, +33 1 56 01 65 74, muriel.fartoukh@aphp.fr
    Scientific contact
    Hôpital Tenon, AP-HP, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, +33 1 56 01 65 74, muriel.fartoukh@aphp.fr
    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
    14 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of a management strategy combining a broad panel respiratory mPCR and an algorithm of early antibiotic de-escalation and discontinuation based on both the mPCR results and the procalcitonin, on antibiotics exposure, as compared with a conventional strategy, in severe confirmed COVID-19 pneumonia.
    Protection of trial subjects
    Patients benefit from specific medical monitoring. AP-HP has taken all measures to conduct this research in accordance with the provisions of the Public Health Code applicable to research involving humans.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 194
    Worldwide total number of subjects
    194
    EEA total number of subjects
    194
    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)
    83
    From 65 to 84 years
    109
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Participants to be recruited among adults with COVID-19 pneumonia admitted to the IC.

    Pre-assignment
    Screening details
    Participants to be recruited among adults with COVID-19 pneumonia admitted to the IC, the screening is done according to the recruiting criterias.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Conventional strategy
    Arm description
    Conventional strategy, in severe confirmed COVID-19 pneumonia.
    Arm type
    Control arm

    Investigational medicinal product name
    antibiotics
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection, Cachet
    Routes of administration
    Buccal use, Intravenous use
    Dosage and administration details
    Conventional dosage

    Arm title
    mPCR FA-PPP and PCT
    Arm description
    A strategy combining a mPCR FA-PPP and an algorithm of early antibiotics adaptation and discontinuation based on both the mPCR FA-PPP results and the PCT.
    Arm type
    Experimental

    Investigational medicinal product name
    antibiotics
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cachet, Solution for injection/infusion
    Routes of administration
    Buccal use, Intracavernous use
    Dosage and administration details
    Adminisatration via intravenous or bucal. Dosage will be patient depdendant.

    Number of subjects in period 1
    Conventional strategy mPCR FA-PPP and PCT
    Started
    98
    96
    Completed
    98
    96

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Conventional strategy
    Reporting group description
    Conventional strategy, in severe confirmed COVID-19 pneumonia.

    Reporting group title
    mPCR FA-PPP and PCT
    Reporting group description
    A strategy combining a mPCR FA-PPP and an algorithm of early antibiotics adaptation and discontinuation based on both the mPCR FA-PPP results and the PCT.

    Reporting group values
    Conventional strategy mPCR FA-PPP and PCT Total
    Number of subjects
    98 96 194
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.8 ± 13.8 64.9 ± 12 -
    Gender categorical
    Units: Subjects
        Female
    27 30 57
        Male
    71 66 137

    End points

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    End points reporting groups
    Reporting group title
    Conventional strategy
    Reporting group description
    Conventional strategy, in severe confirmed COVID-19 pneumonia.

    Reporting group title
    mPCR FA-PPP and PCT
    Reporting group description
    A strategy combining a mPCR FA-PPP and an algorithm of early antibiotics adaptation and discontinuation based on both the mPCR FA-PPP results and the PCT.

    Subject analysis set title
    Primary : Number of antibiotic free days at D28
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    The primary assessment criterion is the number of antibiotic free days at D28, which corresponds to the number of days alive without any antibiotics at Day 28. The D28 time point is usual in studies assessing antibiotic use in ICU patients.

    Primary: Primary : Number of antibiotic free days at D28

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    End point title
    Primary : Number of antibiotic free days at D28
    End point description
    The primary assessment criterion is the number of antibiotic free days at D28, which corresponds to the number of days alive without any antibiotics at Day 28. The D28 time point is usual in studies assessing antibiotic use in ICU patients.
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    Conventional strategy mPCR FA-PPP and PCT
    Number of subjects analysed
    98
    93
    Units: days
    14
    12
    Statistical analysis title
    Primary : Number of antibiotic free days at D28
    Comparison groups
    Conventional strategy v mPCR FA-PPP and PCT
    Number of subjects included in analysis
    191
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.895
    Method
    negative binomial distributions
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24
    Frequency threshold for reporting non-serious adverse events: 0%
    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: Unfortunately AE list with SOC are not available yet.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Sep 2020
    - Prolongation de la durée des inclusions de 6 mois, afin de pouvoir compléter les objectifs d’inclusion en cas de deuxième vague de l’épidémie ; - Changement d’Investigateurs dans deux centres participant.
    06 Apr 2021
    - Changement d’Investigateurs dans deux centres participant.

    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
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