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    Clinical Trial Results:
    Shortened Antibiotic Treatment in Community-Acquired Pneumonia: A Nationwide Danish Randomized Controlled Trial

    Summary
    EudraCT number
    		 2019-000404-15
    Trial protocol
    		 DK  
    Global end of trial date
    22 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2026
    First version publication date
    23 Apr 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    34666
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04089787
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Thomas Benfield
    Sponsor organisation address
    Kettegaard Alle 30, Hvidovre, Denmark, 2650
    Public contact
    Simone Bastrup Israelsen, Thomas Benfield, simone.elisabeth.bastrup.israelsen.02@regionh.dk
    Scientific contact
    Simone Bastrup Israelsen, Thomas Benfield, simone.elisabeth.bastrup.israelsen.02@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
    08 Apr 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety of shortened antibiotic treatment duration of community-acquired pneumonia in hospitalized immunocompetent adult patients based on clinical stability criteria in a beta-lactam antibiotic setting
    Protection of trial subjects
    The planned investigations and measurements are not expected to exceed usual clinical care. Pain and discomfort in relation to blood samples for adult patients are regarded insignificant. X-ray radiation in relation to initial chest X-ray is considered an acceptable radiation risk, as the approximate dose of a chest X-ray is only 0,05 mSv corresponding to 6 days of natural background radiation in Denmark.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 2019
    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: 395
    Worldwide total number of subjects
    395
    EEA total number of subjects
    395
    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)
    106
    From 65 to 84 years
    214
    85 years and over
    75

    Subject disposition

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    Recruitment
    Recruitment details
    		 Investigators and treating physicians associated to the research project will identify patients eligible for trial inclusion at day 1-4 after hospital admission. Eligible patients will receive verbal and written information on the study, and subsequently be offered participation.

    Pre-assignment
    Screening details
    		 Day 1 is defined by the initiation of antimicrobial therapy for CAP during hospitalization. Day 1-4 serves as screening period to determine study eligibility. Eligible patients will be included in the trial from day 1 to day 5 and randomized at day 3, 4 or 5.

    Period 1
    Period 1 title
    Intervention (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Data analyst [1]
    Blinding implementation details
    The trial had an open-label design, in which participants, treating physicians, and investigators were aware of treatment allocation, while outcome assessors remained blinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Intervention
    Arm description
    		 Patients were randomly assigned to receive either a short-course (5 days) of antibiotic treatment (intervention group) or a standard-course (≥7 days) of antibiotic treatment (control group). In the intervention group, antibiotic treatment was discontinued after 5 days. Antibiotic type, route, and dosage were left to physician discretion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    piperacillin/tazobactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for dispersion for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    In the intervention group, antibiotic treatment was discontinued after 5 days, whereas in the control group, the duration was determined by the treating physician but had to be at least 7 days. Antibiotic type, route, and dosage were left to physician discretion.

    Arm title
    		 Control
    Arm description
    		 Patients were randomly assigned to receive either a short-course (5 days) of antibiotic treatment (intervention group) or a standard-course (≥7 days) of antibiotic treatment (control group). In the control group, the duration was determined by the treating physician but had to be at least 7 days. Antibiotic type, route, and dosage were left to physician discretion.
    Arm type
    		 Control

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Open-label trial, only outcome assessors remained blinded.
    Number of subjects in period 1
    		Intervention Control
    Started
    198
    197
    Completed
    196
    197
    Not completed
    2
    0
         Consent withdrawn by subject
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Patients were randomly assigned to receive either a short-course (5 days) of antibiotic treatment (intervention group) or a standard-course (≥7 days) of antibiotic treatment (control group). In the intervention group, antibiotic treatment was discontinued after 5 days. Antibiotic type, route, and dosage were left to physician discretion.

    Reporting group title
    Control
    Reporting group description
    		 Patients were randomly assigned to receive either a short-course (5 days) of antibiotic treatment (intervention group) or a standard-course (≥7 days) of antibiotic treatment (control group). In the control group, the duration was determined by the treating physician but had to be at least 7 days. Antibiotic type, route, and dosage were left to physician discretion.

    Reporting group values
    		 Intervention Control Total
    Number of subjects
    		 198 197 395
    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 (inter-quartile range (Q1-Q3))
    		 75 (62 to 84) 76 (64 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 109 102 211
        Male
    		 89 95 184

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 Patients were randomly assigned to receive either a short-course (5 days) of antibiotic treatment (intervention group) or a standard-course (≥7 days) of antibiotic treatment (control group). In the intervention group, antibiotic treatment was discontinued after 5 days. Antibiotic type, route, and dosage were left to physician discretion.

    Reporting group title
    Control
    Reporting group description
    		 Patients were randomly assigned to receive either a short-course (5 days) of antibiotic treatment (intervention group) or a standard-course (≥7 days) of antibiotic treatment (control group). In the control group, the duration was determined by the treating physician but had to be at least 7 days. Antibiotic type, route, and dosage were left to physician discretion.

    Primary: All-cause mortality

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    End point title
    		 All-cause mortality
    End point description
    End point type
    Primary
    End point timeframe
    90-day
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: deaths
    6
    4
    Statistical analysis title
    		 Non-inferiority
    Comparison groups
    Intervention v Control
    Number of subjects included in analysis
    393
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 absolute risk difference
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 -6
         upper limit
    		 -

    Secondary: Readmission

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    End point title
    		 Readmission
    End point description
    End point type
    Secondary
    End point timeframe
    90-day
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: yes/no
    46
    42
    No statistical analyses for this end point

    Secondary: Length of hospital stay

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    End point title
    		 Length of hospital stay
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: days
        number (not applicable)
    4.0
    3.9
    No statistical analyses for this end point

    Secondary: Duration of antibiotic therapy

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    End point title
    		 Duration of antibiotic therapy
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: days
        number (not applicable)
    5.0
    7.1
    No statistical analyses for this end point

    Secondary: New antibiotic treatment

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    End point title
    		 New antibiotic treatment
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: yes/no
    45
    38
    No statistical analyses for this end point

    Secondary: Follow-up visits

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    End point title
    		 Follow-up visits
    End point description
    End point type
    Secondary
    End point timeframe
    90 days
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: yes/no
    54
    36
    No statistical analyses for this end point

    Secondary: Mortality

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    End point title
    		 Mortality
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: yes/no
    2
    2
    No statistical analyses for this end point

    Secondary: Readmission

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    End point title
    		 Readmission
    End point description
    End point type
    Secondary
    End point timeframe
    30 days
    End point values
    		 Intervention Control
    Number of subjects analysed
    196
    197
    Units: yes/no
    25
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    90 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    		 -

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 Intervention Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    49 / 196 (25.00%)
    49 / 197 (24.87%)
         number of deaths (all causes)
    6
    4
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Hospital admission/prolonged hospital stay
         subjects affected / exposed
    49 / 196 (25.00%)
    49 / 197 (24.87%)
         occurrences causally related to treatment / all
    5 / 57
    0 / 72
         deaths causally related to treatment / all
    0 / 6
    0 / 4
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Intervention Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 196 (14.80%)
    32 / 197 (16.24%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 196 (0.00%)
    2 / 197 (1.02%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    1 / 196 (0.51%)
    3 / 197 (1.52%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 196 (1.02%)
    4 / 197 (2.03%)
         occurrences all number
    2
    4
    Vomiting
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 197 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    20 / 196 (10.20%)
    23 / 197 (11.68%)
         occurrences all number
    20
    23
    Abdominal pain
         subjects affected / exposed
    3 / 196 (1.53%)
    2 / 197 (1.02%)
         occurrences all number
    3
    2
    Hepatobiliary disorders
    Elevated liver enzymes
         subjects affected / exposed
    2 / 196 (1.02%)
    1 / 197 (0.51%)
         occurrences all number
    2
    1
    Skin and subcutaneous tissue disorders
    Skin rash
         subjects affected / exposed
    2 / 196 (1.02%)
    1 / 197 (0.51%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    Elevated creatinine levels
         subjects affected / exposed
    1 / 196 (0.51%)
    0 / 197 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Nov 2023
    Change in primary outcome from composite of 90-day mortality and readmissions to only 90-day mortality and recalculation of sample size due to change in primary outcome and adjustment of confidence intervals (90% to 95%) in accordance with latest updated guidelines.

    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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