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    Clinical Trial Results:
    Biomarker guided antibiotic treatment in Community-Acquired Pneumoni (BIO-CAP)

    Summary
    EudraCT number
    		 2015-002501-11
    Trial protocol
    		 DK  
    Global end of trial date
    30 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Sep 2021
    First version publication date
    15 Sep 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BIO-CAP_2015
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nordsjællands Hospital
    Sponsor organisation address
    Dyrehavevej 29, Hillerød, Denmark,
    Public contact
    Gertrud Baunbæk-Knudsen, Nordsjællands Hospital, +45 26220865, gertrud.louise.baunbaek-knudsen@regionh.dk
    Scientific contact
    Gertrud Baunbæk-Knudsen, Nordsjællands Hospital, +45 26220865, gertrud.louise.baunbaek-knudsen@regionh.dk
    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
    30 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of biomarker algorithms to reduce duration of antibiotic exposure in patients hospitalized with CAP compared to standard of care and to evaluate the efficacy of an algorithm based on C-reactive protein compared to an algorithm based on Procalcitonin for this purpose.
    Protection of trial subjects
    Participants were treated according to guidelines in regards to choice of antibiotic agent. The intervention determined the length of treatment in the intervention groups, however, we determined a minimum treatment length according to current evidence of 72-hours. Further, the discontinuation of antibiotic treatment according to the biomarker algorithms could be overruled by the treating physician.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2017
    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
    Denmark: 300
    Worldwide total number of subjects
    300
    EEA total number of subjects
    300
    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)
    99
    From 65 to 84 years
    163
    85 years and over
    38

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were recruited from 01-Mar-2017 - 01-Mar-2020.

    Pre-assignment
    Screening details
    		 Adult patients (18 years or older) admitted to Nordsjællands Hospital with symptoms compatible with Community Acquired Pneumonia (CAP) were screened for inclusion. The primay causes for no inclusion were no infiltrate on chest x-ray, inability to comprehend study material or unwillingnes to participate.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CRP-group
    Arm description
    		 Antibiotic treatment were given for minimum 72 hours. After this time point antibiotic treatment were continued/discontinued according to the CRP biomarker algorithm: CRP < 50 g/dl: discontinue antibiotic treatment CRP < 75 g/dl and CRP ≥ 50 g/dl and CRP has decreased with at least 20% within the last 24 hours: discontinue antibiotic treatment CRP ≥ 75 g/dl: continue antibiotic treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Amoxicillin/clavulansyre
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ampicillin "PCD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ampicillin ”PCD”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Benzylpenicillin ”Panpharma”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Cefuroxim ”Stragen”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ciprofloxacin ”Fresenius Kabi”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ciprofloxacin “Actavis”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Clarithromycin ”Paranova”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Clarithromycin ”Hexal”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Dicloxacillin ”Actavis”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Doxycyclin Europharma
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Meropenem ”Fresenius Kabi”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Moxifloxacin ”Orion”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Moxifloxacin "Actavis",
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Piperacillin/Tazobactam ”Fresenius Kabi”,
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Roxithromycin ”Orifarm”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Vepicombin Novum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Arm title
    		 Control-group
    Arm description
    		 Participant are treated according to current guidelines.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 PCT-group
    Arm description
    		 Antibiotic treatment were given for minimum 72 hours. After this time point antibiotic treatment were continues/discontinued according to the PCT (procalcitonin) biomarker algorithm: PCT < 0,25 µg/l : discontinue antibiotic treatment CRP ≥ 0,25 µg/l : continue antibiotic treatment
    Arm type
    		 intervention

    Investigational medicinal product name
    Amoxicillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Amoxicillin/clavulansyre
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ampicillin "PCD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ampicillin ”PCD”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Benzylpenicillin ”Panpharma”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Cefuroxim ”Stragen”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ciprofloxacin ”Fresenius Kabi”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Ciprofloxacin “Actavis”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Clarithromycin ”Paranova”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency was determined by the treating physician

    Investigational medicinal product name
    Clarithromycin ”Hexal”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Dicloxacillin ”Actavis”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Doxycyclin Europharma
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Meropenem ”Fresenius Kabi”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Moxifloxacin ”Orion”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Moxifloxacin "Actavis",
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Piperacillin/Tazobactam ”Fresenius Kabi”,
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Roxithromycin ”Orifarm”
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Investigational medicinal product name
    Vepicombin Novum
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage and frequency were determined by the treating physician

    Number of subjects in period 1
    		CRP-group Control-group PCT-group
    Started
    100
    101
    99
    Completed
    100
    101
    99

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Intervention (overall period) Total
    Number of subjects
    		 300 300
    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
        median (full range (min-max))
    		 73 (23 to 96) -
    Gender categorical
    Units: Subjects
        Female
    		 155 155
        Male
    		 145 145

    End points

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    End points reporting groups
    Reporting group title
    CRP-group
    Reporting group description
    		 Antibiotic treatment were given for minimum 72 hours. After this time point antibiotic treatment were continued/discontinued according to the CRP biomarker algorithm: CRP < 50 g/dl: discontinue antibiotic treatment CRP < 75 g/dl and CRP ≥ 50 g/dl and CRP has decreased with at least 20% within the last 24 hours: discontinue antibiotic treatment CRP ≥ 75 g/dl: continue antibiotic treatment

    Reporting group title
    Control-group
    Reporting group description
    		 Participant are treated according to current guidelines.

    Reporting group title
    PCT-group
    Reporting group description
    		 Antibiotic treatment were given for minimum 72 hours. After this time point antibiotic treatment were continues/discontinued according to the PCT (procalcitonin) biomarker algorithm: PCT < 0,25 µg/l : discontinue antibiotic treatment CRP ≥ 0,25 µg/l : continue antibiotic treatment

    Primary: Length of antibiotic treament

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    End point title
    		 Length of antibiotic treament
    End point description
    End point type
    Primary
    End point timeframe
    Within 30 days from inclusion
    End point values
    		 CRP-group Control-group PCT-group
    Number of subjects analysed
    100
    101
    99
    Units: Days
    7
    9
    7
    Statistical analysis title
    		 Primary outcome
    Statistical analysis description
    Comparisons of length of antibiotic treatment (days) between the CRP-group and the control group
    Comparison groups
    CRP-group v Control-group
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - We used the Wilcoxon Rank sum test as the assumption of a normal distribution was not met.
    Statistical analysis title
    		 Primary outcome
    Comparison groups
    PCT-group v CRP-group
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.38
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: treatment failure

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    End point title
    		 treatment failure
    End point description
    treatment failure was defined as readmission or renewed antibiotic treatment due to pneumonia.
    End point type
    Secondary
    End point timeframe
    within 30 days of inclusion
    End point values
    		 CRP-group Control-group PCT-group
    Number of subjects analysed
    100
    101
    99
    Units: yes/no
    19
    27
    15
    Statistical analysis title
    		 Treatment failure
    Statistical analysis description
    Number of patients who experienced treatment failure in the control-group versus the number of patients who experienced treatment failure in the CRP-group
    Comparison groups
    CRP-group v Control-group
    Number of subjects included in analysis
    201
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.19
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Treatment failure
    Statistical analysis description
    Number of patients who experienced treatment failure in the control-group versus number of patients who experienced treatment failure in the PCT-group
    Comparison groups
    PCT-group v CRP-group
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.56
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    May 2016 until 30-March-2021
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    CRP-group
    Reporting group description
    		 -

    Reporting group title
    PCT-group
    Reporting group description
    		 -

    Reporting group title
    control-group
    Reporting group description
    		 -

    Serious adverse events
    		 CRP-group PCT-group control-group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    23 / 100 (23.00%)
    16 / 99 (16.16%)
    25 / 101 (24.75%)
         number of deaths (all causes)
    4
    3
    5
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung cancer metastatic
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Confusional state
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Death
    Additional description: One patient was found death during admission, overdose was suspected, however, no autopsy was performed. Four patients died outside of hospital, all of them where known with severe chronic disorders.
         subjects affected / exposed
    1 / 100 (1.00%)
    2 / 99 (2.02%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
    Additional description: exacerbation
         subjects affected / exposed
    1 / 100 (1.00%)
    3 / 99 (3.03%)
    3 / 101 (2.97%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sputum abnormal
    Additional description: Hemoptysis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 99 (1.01%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    Dyspnoea
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Endocrine disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Hip disarticulation
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammation
    Additional description: Suspected to have venous trombosis in lower limb, rouled out with ultrasound
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 100 (5.00%)
    3 / 99 (3.03%)
    9 / 101 (8.91%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 99 (1.01%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 99 (0.00%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 99 (1.01%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 CRP-group PCT-group control-group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 100 (23.00%)
    29 / 99 (29.29%)
    34 / 101 (33.66%)
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    0
    0
    0
    Respiratory acidosis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    2
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    1
    0
    1
    Bradycardia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Fluid overload
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences all number
    1
    1
    0
    Chest pain
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Phlebitis
         subjects affected / exposed
    1 / 100 (1.00%)
    4 / 99 (4.04%)
    0 / 101 (0.00%)
         occurrences all number
    1
    4
    0
    Anaemia
         subjects affected / exposed
    1 / 100 (1.00%)
    2 / 99 (2.02%)
    0 / 101 (0.00%)
         occurrences all number
    1
    2
    0
    Oedema
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    2 / 101 (1.98%)
         occurrences all number
    1
    0
    2
    Diarrhoea
         subjects affected / exposed
    1 / 100 (1.00%)
    6 / 99 (6.06%)
    1 / 101 (0.99%)
         occurrences all number
    1
    6
    1
    Vomiting
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 99 (1.01%)
    1 / 101 (0.99%)
         occurrences all number
    1
    1
    1
    Haematochezia
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    0
    Gastritis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    2 / 101 (1.98%)
         occurrences all number
    0
    0
    2
    Constipation
         subjects affected / exposed
    3 / 100 (3.00%)
    1 / 99 (1.01%)
    4 / 101 (3.96%)
         occurrences all number
    3
    1
    4
    Abscess oral
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatobiliary disorders
    Liver function test
    Additional description: elevated liverenzymes
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 99 (2.02%)
    2 / 101 (1.98%)
         occurrences all number
    0
    2
    2
    Skin irritation
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 100 (1.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences all number
    1
    1
    0
    Haematuria
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    Endocrine disorders
    Adrenal mass
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    pain
         subjects affected / exposed
    1 / 100 (1.00%)
    3 / 99 (3.03%)
    1 / 101 (0.99%)
         occurrences all number
    1
    4
    1
    Fracture
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 99 (1.01%)
    0 / 101 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    0
    Bacterial test positive
    Additional description: Colonization with vancomcin-resistant Enterococcus
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    2 / 101 (1.98%)
         occurrences all number
    1
    0
    2
    Lung abscess
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    0
    Abscess soft tissue
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 99 (0.00%)
    0 / 101 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    10 / 100 (10.00%)
    7 / 99 (7.07%)
    11 / 101 (10.89%)
         occurrences all number
    10
    7
    11
    Hyponatraemia
         subjects affected / exposed
    0 / 100 (0.00%)
    2 / 99 (2.02%)
    1 / 101 (0.99%)
         occurrences all number
    0
    2
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 100 (1.00%)
    2 / 99 (2.02%)
    0 / 101 (0.00%)
         occurrences all number
    1
    2
    0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 99 (0.00%)
    1 / 101 (0.99%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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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