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NCT Number: NCT06045429

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

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.

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Key information

Conditions

VAP - Ventilator Associated Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 of respiratory infection 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

Treatment and study plan

Oroxid®

Drug

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.

Other names: 3% hydrogen peroxide mouthwash

Chlorhexidine mouthwash

Drug

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

Other names: 0,2% chlorhexidine gluconate

Primary outcomes

  1. Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.

    Time frame: 18 months

    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 outcomes

  1. Differences in the relative risk of infection related ventilator associated complications (IVAC)

    Time frame: 18 months

    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

  2. ATB exposure at discharge

    Time frame: From the date of enrolment through to the date of ICU discharge, approximately 28 days

    Duration of antibiotics prescribed at discharge

  3. Intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU.

    Time frame: will be measured at 24 hours (T1), day 3 (T2), day 7 (T3) and day 14 (T4) after admission

    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

  4. Length of ICU stay in days

    Time frame: at 3 months

    that is, length of ICU stay in days

  5. 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

Other outcomes

  1. Composition of the oral and lower airway microbiome between groups measured by the bacterial 16S rRNA sequencing

    Time frame: day 0, day 7 and day 14

    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.

  2. Antibiotic Free Days

    Time frame: up to 30 days

    The number of days where participant did not require the use of antibiotics

  3. The number of participants with Non-pulmonary infections

    Time frame: up to 30 days

    The number of participants with Non-pulmonary infections

Study contacts

Contact information is provided by the study sponsor or research team.

Adela Jiroudkova

CONTACT

[email protected]

+420 602 145 168

Kateřina Rambousková, MD

CONTACT

[email protected]

+420 721 185 134

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study 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

Acronym: HyperMICROBE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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