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    Clinical Trial Results:
    Effects of antibiotics on micobiota, pulmonary immune response and incidence of ventilator-associated infections

    Summary
    EudraCT number
    		 2018-000492-32
    Trial protocol
    		 DE  
    Global end of trial date
    17 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Mar 2024
    First version publication date
    07 Mar 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AMIII
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité -Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Dr. med Charlotte Thibeault (born Keller), Medizinische Klinik m.S. Infektiologie und Pneumologie, +49 30450665065, charlotte.thibeault@charite.de
    Scientific contact
    PD Dr. med. Holger Müller-Redetzky, Medizinische Klinik m.S. Infektiologie und Pneumologie, +49 30450653336, holger.mueller-redetzky@charite.de
    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
    20 Sep 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Feb 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Main objective of the trial is to study the effect of antibiotic therapies on pulmonary immunoglobulin A (IgA) in mechanically ventilated patients. Based on data from mouse models and a pilot study from our research group, we assume that antibiotic therapies reduce pulmonary IgA level.
    Protection of trial subjects
    To determine the suitability of a patient, the inclusion and exclusion criteria are checked that there are no comorbidities or allergies that would constitute an exclusion criterion and that the inclusion criteria for inclusion in the antibiotic or control group are met. Assessment of the patient's clinical stability and evaluation of the risk of bronchoscopy by the investigator based on the patient's medical history, continuously recorded vital signs, clinical examination and ECG. Bronchoscopy is performed by an experienced examiner under continuous monitoring. To prevent and control possible complications, patients who are in an unstable clinical situation were excluded in advance. The strict use of concomitant medication in accordance with the information for healthcare professionals and the exclusion or premature discontinuation of patients for whom this is not guaranteed represents a further risk-minimizing measure. To minimize the risk of emergency situations occurring, only patients in a stable clinical situation were included and in which the antibiotic therapy was carried out in accordance with the approval and specialist information.
    Background therapy
    		 Patients who have received antibiotic therapy for 7-10 days within standard care are eligible for inclusion in the AMIII- arm, because effects of clinically revelant broad-spectrum antibiotic therapies were to be studied. Therefore, the treatment arm encompasses 24 different currently widely used IMPs with activity against gram-positive, gram-negative and anaerobic bacteria as well as combination therapies, as long as antibiotic therapies followed SMPCs and were carried out according to national guidelines. Patients who have not received any antibiotic therapy for at least 90 days are eligible for inclusion in the control arm.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Mar 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
    Germany: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    5
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at one study center in Germany, between 07/05/2019 (date of first enrollment) and 15/04/2020 (LPLV). Using the available documentation systems inpatients on the intensive care unit (18 beds) and the two home respiratory wards (12+13 beds) were daily-screened according inclusion routine parameters by the study team.

    Pre-assignment
    Screening details
    		 Adults inpatients invasive or intermittent invasive ventilation via tracheostomy tube either no antibiotic therapy for a longer period (≥90 days) or completed antibiotic therapy (7-10 days) with efficacy in the gram-positive, gram-negative and anaerobic range as part of the clinical routine in accordance with the approval were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AMIII-group
    Arm description
    		 Inpatients with invasive or intermittent invasive ventilation via tracheostomy tube with completed course of 7-10 days of antibiotic therapy with antimicrobial activity against Gram-negative, Gram-positive and anaerobic bacteria according to SmPC and to marketing authorization. Treatment ended ≥ 5x elimination half-time of the trade product prior AND not more than 72hrs prior to inclusion. Brochoscopy was performed using a local anesthesia of the bronchi (Lidocain) and concomitant medication administered for sedation ( Midazolam/ Propofol) during brochoscopy outside of routine clinical practice.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amoxicillin Trihydrate
    Investigational medicinal product code
    SUB00504MIG
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    within standard care according to SmPCs

    Investigational medicinal product name
    CLAVULANIC ACID
    Investigational medicinal product code
    58001-44-8
    Other name
    SUB06642MIG
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    within standard of care and according to SmPCs

    Investigational medicinal product name
    Ampicillin
    Investigational medicinal product code
    SUB00508MIG
    Other name
    AMPICILLIN SODIUM
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Sulbactam
    Investigational medicinal product code
    SUB04617MIG
    Other name
    SULBACTAM SODIUM
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Cefazolin
    Investigational medicinal product code
    SUB01107MIG
    Other name
    CEFAZOLIN SODIUM
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    CEFEPIME HYDROCHLORIDE
    Investigational medicinal product code
    123171-59-5
    Other name
    SUB01113MIG
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    CEFTAZIDIME
    Investigational medicinal product code
    72558-82-8
    Other name
    SUB07422MIG
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Ceftazidime Pentahydrate
    Investigational medicinal product code
    SUB01134MIG
    Other name
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Avibactam
    Investigational medicinal product code
    SUB179984
    Other name
    AVIBACTAM SODIUM
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Ceftolozane
    Investigational medicinal product code
    SUB167761
    Other name
    CEFTOLOZANE SULFATE
    Pharmaceutical forms
    Powder for concentrate and solution for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Tazobactam Sodium
    Investigational medicinal product code
    SUB04682MIG
    Other name
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Ceftriaxone Disodium
    Investigational medicinal product code
    SUB26591
    Other name
    CEFTRIAXONE DISODIUM
    Pharmaceutical forms
    Powder and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Ciprofloxacin
    Investigational medicinal product code
    SUB182757
    Other name
    CIPROFLOXACIN HYDROGEN SULPHATE
    Pharmaceutical forms
    Powder for solution for injection/infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Ciprofloxacin Hydrochloride Monohydrate
    Investigational medicinal product code
    86393-32-0
    Other name
    SUB25858
    Pharmaceutical forms
    Powder for solution for injection/infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Ciprofloxacin lactate
    Investigational medicinal product code
    SUB01317MIG
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Clarithromycin
    Investigational medicinal product code
    SUB06641MIG
    Other name
    Pharmaceutical forms
    Film-coated tablet, Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Clarithromycin lactobionate
    Investigational medicinal product code
    SUB20333
    Other name
    Pharmaceutical forms
    Film-coated tablet, Powder for solution for injection/infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Clindamycin
    Investigational medicinal product code
    SUB01344MIG
    Other name
    CLINDAMYCIN PHOSPHATE
    Pharmaceutical forms
    Powder for solution for injection/infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    DAPTOMYCIN
    Investigational medicinal product code
    103060-53-3
    Other name
    SUB06910MIG
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    ERTAPENEM SODIUM
    Investigational medicinal product code
    153773-82-1
    Other name
    SUB16424MIG
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    FLUCLOXACILLIN SODIUM
    Investigational medicinal product code
    1847-24-1
    Other name
    SUB02207MIG
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    GENTAMICIN SULFATE
    Investigational medicinal product code
    1405-41-0
    Other name
    SUB02327MIG
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Imipenem Monohydrate
    Investigational medicinal product code
    74431-23-5
    Other name
    SUB21472
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Cilastatin Sodium
    Investigational medicinal product code
    SUB01295MIG
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Linezolid
    Investigational medicinal product code
    SUB08520MIG
    Other name
    Pharmaceutical forms
    Solution for injection/infusion, Film-coated tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Meropenem Trihydrate
    Investigational medicinal product code
    SUB21617
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    METRONIDAZOLE
    Investigational medicinal product code
    SUB08922MIG
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    subject received 5mg/ml

    Investigational medicinal product name
    Piperacillin
    Investigational medicinal product code
    SUB03840MIG
    Other name
    PIPERACILLIN SODIUM
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Tazobactam
    Investigational medicinal product code
    SUB04682MIG
    Other name
    TAZOBACTAM SODIUM
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Tobramycin
    Investigational medicinal product code
    SUB11134MIG
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    TOBRAMYCIN SULFATE
    Investigational medicinal product code
    79645-27-5
    Other name
    SUB04896MIG
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    TRIMETHOPRIM
    Investigational medicinal product code
    23256-42-0
    Other name
    SUB04972MIG
    Pharmaceutical forms
    Tablet, Concentrate for solution for infusion
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    SULFAMETHOXAZOLE
    Investigational medicinal product code
    723-46-6
    Other name
    SUB10711MIG
    Pharmaceutical forms
    Concentrate for solution for infusion, Concentrate for solution for injection/infusion, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Vancomycin
    Investigational medicinal product code
    SUB05077MIG
    Other name
    VANCOMYCIN HYDROCHLORIDE
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    TIGECYCLINE
    Investigational medicinal product code
    220620-09-7
    Other name
    SUB16467MIG
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care and according to SmPCs

    Investigational medicinal product name
    Tigecycline
    Investigational medicinal product code
    Other name
    Tygacil
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    within standard care according to SmPCs

    Arm title
    		 control-group
    Arm description
    		 Inpatients invasive or intermittent invasive ventilation via tracheostomy tube either no antibiotic therapy for a longer period (≥90 days),a brochoscopy was performed using a local anesthesia of the bronchi (Lidocain) and concomitant medication administered for sedation ( Midazolam/ Propofol) during brochoscopy outside of routine clinical practice.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		AMIII-group control-group
    Started
    8
    4
    Completed
    8
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    AMIII-group
    Reporting group description
    		 Inpatients with invasive or intermittent invasive ventilation via tracheostomy tube with completed course of 7-10 days of antibiotic therapy with antimicrobial activity against Gram-negative, Gram-positive and anaerobic bacteria according to SmPC and to marketing authorization. Treatment ended ≥ 5x elimination half-time of the trade product prior AND not more than 72hrs prior to inclusion. Brochoscopy was performed using a local anesthesia of the bronchi (Lidocain) and concomitant medication administered for sedation ( Midazolam/ Propofol) during brochoscopy outside of routine clinical practice.

    Reporting group title
    control-group
    Reporting group description
    		 Inpatients invasive or intermittent invasive ventilation via tracheostomy tube either no antibiotic therapy for a longer period (≥90 days),a brochoscopy was performed using a local anesthesia of the bronchi (Lidocain) and concomitant medication administered for sedation ( Midazolam/ Propofol) during brochoscopy outside of routine clinical practice.

    Primary: change IGA (BALF)

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    End point title
    		 change IGA (BALF) [1]
    End point description
    pulmonary IgA as measured in broncheoalveolar lavage fluid (BALF)
    End point type
    Primary
    End point timeframe
    on day 0-2
    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: The steering committee of the trial voted against an analysis of primary and secondary endpoints other than safety endpoints, because of the expected low accuracy of results. Due to the low number of recruited patients (n=12, with 8 patients being in the AMIII-arm), the results of the primary endpoint level of IgA in the broncheoalveolar fluid are expected to be influenced more by interindividual differences than effects of antibiotic therapy and therefore, a specific analysis would not lead to.
    End point values
    		 AMIII-group control-group
    Number of subjects analysed
    8
    4
    Units: mg/dl
        arithmetic mean (standard error)
    0 ( 0 )
    0 ( 0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    relative frequency of SAE/AE- day 1-3
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    AMIII-group
    Reporting group description
    		 -

    Reporting group title
    Control-group
    Reporting group description
    		 -

    Serious adverse events
    		 AMIII-group Control-group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 AMIII-group Control-group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    3 / 4 (75.00%)
    Investigations
    Increase of tracheal secretion
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    2
    Hypotension
         subjects affected / exposed
    4 / 8 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Tremur
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Dyspnea
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Hypoxia
         subjects affected / exposed
    2 / 8 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    Productive cough
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    other: local infection at tracheostoma
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2019
    update protocol Version 1.2 (23/01/2019) and ICF V1.2
    18 Dec 2019
    update Protocol V1.2 (2019/01/23) to Protocol V1.3 : - Change in inclusion criteria from - Antibiotic therapy at inclusion for 24-72h≥ 5x half-life of the drug used and completed - New Sample collection from gastric juice in patients with a gastric tube - add drug of antibiotic therapy (Tigecyclin i.v.)

    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.
    Due to the ongoing pandemic caused by the SARS-CoV-2 virus and its repercussion in the health sector, no patients could be included in the trial since march 2020. Delay in recruitment led to relevant risks concerning feasibility and business plan of
    For support, Contact us.
    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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