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Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation (HyperMICROBE)

Primary Purpose

VAP - Ventilator Associated Pneumonia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Oroxid®
Chlorhexidine mouthwash
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for VAP - Ventilator Associated Pneumonia focused on measuring pneumonia, hydrogen peroxide, chlorhexidine, respiratory tract microbiome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years In-patient of ICU and expected to stay > 5 days Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline No history and symptoms of aspiration at the baseline Exclusion Criteria: ATB therapy on admission Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation Pregnancy Oral ulcers or injuries Patient with a history of hydrogen peroxide allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Hydrogen Peroxide

    Chlorhexidine

    Arm Description

    Intervention group: daily oral care will be provided according to the local standard, with 3% hydrogen peroxide, oral assessment and teeth brushing will be completed twice daily (morning and evening).

    Control group: daily oral care will be provided according to the local standard, with 0,2% chlorhexidine, oral assessment and teeth brushing will be completed twice daily (morning and evening).

    Outcomes

    Primary Outcome Measures

    Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.
    To detect microorganisms in the lower respiratory tract, tracheal aspirate will be directly cultured for detecting Gram-positive, Gram-negative, and anaerobic bacteria and fungi. Standard microbial surveillance (tracheal aspirate) will be performed on admission, twice a week (Monday, Thursday) and always ad hoc according to the clinical situation.

    Secondary Outcome Measures

    Differences in the relative risk of infection related ventilator associated complications (IVAC)
    According to the Centers for Disease Control and Prevention (CDC) criteria, the IVAC diagnosis will be established based on: an increase of the daily minimum positive end-expiratory pressure (PEEP) of ≥3 cm H2O and/or the daily minimum inspired oxygen fraction (FiO2) of ≥20 points sustained for ≥2 days and an evidence of a new infection present (abnormal temperature or white blood cell count) and prescription of a new antibiotic for ≥4 days
    ATB exposure at discharge
    Duration of antibiotics prescribed at discharge
    Intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU.
    BOE score ranges from 8 (excellent oral health) to 24 (poor oral health). The BOE scores ranging from 8-10 are considered as indicative of excellent oral health, from 11-14 as moderately impaired oral health and from 15-24 as significantly impaired oral health
    Length of ICU stay in days
    that is, length of ICU stay in days
    Number of ventilator-free days;
    that is, number of days, out of 28 days after admission, that patient has not been supported by mechanical ventilation

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Charles University, Czech Republic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045429
    Brief Title
    Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation
    Acronym
    HyperMICROBE
    Official Title
    Effects of Oral Care With 3% Hydrogen Peroxide (Oroxid®) on the Lower Respiratory Tract Microbial Colonisation in Mechanically Ventilated Adult Critically Ill Patients (HyPer-MICROBE Trial); a Single-centre, Randomised, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    March 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Charles University, Czech Republic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    HyPerMICROBE is a single-centre, controlled, randomised, prospective, superiority clinical trial to compare the efficacy of daily oral care with 3% hydrogen peroxide (Oroxid®) versus standard of care (0.2% chlorhexidine digluconate) on the cumulative incidence of lower respiratory tract microbial colonisation in mechanically ventilated adult critically ill patients.
    Detailed Description
    Rationale: Ventilator-associated pneumonia (VAP) is the most common hospital-acquired infection (HAI) in the intensive care unit (ICU), and its impact is very high in terms of morbidity, length of hospital stay and overall costs. Chlorhexidine for oral care in critically ill has no clear impact on VAP rates and may cause harm. 3% hydrogen peroxide (Oroxid) could be a promising substitute. Aim: To test effectivity and safety of 3% hydrogen peroxide solution on ventilator-associated complications Design: Prospective, single center, parallel group randomised controlled trial. Subjects: ICU patients (general ICU) Treatment in the intervention group: daily oral care with 3% hydrogen peroxide Control group: Standard-of-care protocolised daily oral care with 0,2% chlorhexidine Primary outcome: Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h. Secondary and exploratory outcomes: Differences in the relative risk of infection related ventilator-associated complications, antibiotic (ATB) consumption analysis, intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU, length of ICU stay in days (time frame: at 3 months), number of ventilator-free days (time frame: at 28 days); that is, number of days, out of 28 days after admission, that patient has not been supported by mechanical ventilation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    VAP - Ventilator Associated Pneumonia
    Keywords
    pneumonia, hydrogen peroxide, chlorhexidine, respiratory tract microbiome

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Eligible patients will be recruited in medical-surgical ICU at Kralovske Vinohrady University Hospital (FNKV), managed under an intensivist-led closed ICU, with a 1:1 nurse-to-patient ratio and randomised in equal proportions between 3% hydrogen peroxide arm and 0,2% chlorhexidine digluconate arm.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Due to the nature of the intervention nurses can't be blinded to allocation (the mouthwash type - nature of the fluid, its odour etc.), but are strongly inculcated not to disclose the allocation status of the participant at the follow up assessments. As the ICU is paperless and fully computerised, the data in the computer can be acquired and analysed by the researchers without having access to information about the allocation.
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydrogen Peroxide
    Arm Type
    Experimental
    Arm Description
    Intervention group: daily oral care will be provided according to the local standard, with 3% hydrogen peroxide, oral assessment and teeth brushing will be completed twice daily (morning and evening).
    Arm Title
    Chlorhexidine
    Arm Type
    Active Comparator
    Arm Description
    Control group: daily oral care will be provided according to the local standard, with 0,2% chlorhexidine, oral assessment and teeth brushing will be completed twice daily (morning and evening).
    Intervention Type
    Drug
    Intervention Name(s)
    Oroxid®
    Other Intervention Name(s)
    3% hydrogen peroxide mouthwash
    Intervention Description
    All patients in experimental arm will receive usual best medical and nursing care with respect to VAP prevention including recently reviewed local "ventilator bundle "; standard microbial surveillance (tracheal aspirate) will be performed twice a week (Monday, Thursday) and always ad hoc according to the clinical situation. This reflects current practice. Daily oral care will be provided using Oroxid® mouthwash.
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidine mouthwash
    Other Intervention Name(s)
    0,2% chlorhexidine gluconate
    Intervention Description
    All patients in experimental arm will receive usual best medical and nursing care with respect to VAP prevention including recently reviewed local "ventilator bundle "; standard microbial surveillance (tracheal aspirate) will be performed twice a week (Monday, Thursday) and always ad hoc according to the clinical situation. This reflects current practice. Daily oral care will be provided using 0,2% chlorhexidine
    Primary Outcome Measure Information:
    Title
    Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.
    Description
    To detect microorganisms in the lower respiratory tract, tracheal aspirate will be directly cultured for detecting Gram-positive, Gram-negative, and anaerobic bacteria and fungi. Standard microbial surveillance (tracheal aspirate) will be performed on admission, twice a week (Monday, Thursday) and always ad hoc according to the clinical situation.
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    Differences in the relative risk of infection related ventilator associated complications (IVAC)
    Description
    According to the Centers for Disease Control and Prevention (CDC) criteria, the IVAC diagnosis will be established based on: an increase of the daily minimum positive end-expiratory pressure (PEEP) of ≥3 cm H2O and/or the daily minimum inspired oxygen fraction (FiO2) of ≥20 points sustained for ≥2 days and an evidence of a new infection present (abnormal temperature or white blood cell count) and prescription of a new antibiotic for ≥4 days
    Time Frame
    18 months
    Title
    ATB exposure at discharge
    Description
    Duration of antibiotics prescribed at discharge
    Time Frame
    From the date of enrolment through to the date of ICU discharge, approximately 28 days
    Title
    Intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU.
    Description
    BOE score ranges from 8 (excellent oral health) to 24 (poor oral health). The BOE scores ranging from 8-10 are considered as indicative of excellent oral health, from 11-14 as moderately impaired oral health and from 15-24 as significantly impaired oral health
    Time Frame
    will be measured at 24 hours (T1), day 3 (T2), day 7 (T3) and day 14 (T4) after admission
    Title
    Length of ICU stay in days
    Description
    that is, length of ICU stay in days
    Time Frame
    at 3 months
    Title
    Number of ventilator-free days;
    Description
    that is, number of days, out of 28 days after admission, that patient has not been supported by mechanical ventilation
    Time Frame
    at 28 days
    Other Pre-specified Outcome Measures:
    Title
    Composition of the oral and lower airway microbiome between groups measured by the bacterial 16S rRNA sequencing
    Description
    Microbial DNA will be sequentially (on admission, day 3, 7 and 14) sampled and isolated from prespecified sites in oral cavity, hypopharynx and lower respiratory tract. Microbial DNA will be analyzed by 16S rRNA amplicon sequencing and quantified by multiplex qPCR method. Paired comparison of bacteriomes between intervention group and control group will be performed to identify potentially risky host bacteriome profiles.
    Time Frame
    day 0, day 7 and day 14
    Title
    Antibiotic Free Days
    Description
    The number of days where participant did not require the use of antibiotics
    Time Frame
    up to 30 days
    Title
    The number of participants with Non-pulmonary infections
    Description
    The number of participants with Non-pulmonary infections
    Time Frame
    up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥18 years In-patient of ICU and expected to stay > 5 days Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline No history and symptoms of aspiration at the baseline Exclusion Criteria: ATB therapy on admission Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation Pregnancy Oral ulcers or injuries Patient with a history of hydrogen peroxide allergy

    12. IPD Sharing Statement

    Learn more about this trial

    Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation

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