Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Oroxid®
DrugAll 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.
Chlorhexidine mouthwash
DrugAll 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
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Hydrogen PeroxideExperimental treatment 1 intervention
Group B: ChlorhexidineActive comparator 1 intervention
Trial outcomes
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.
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 monthsSecondary outcomes
1
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
Time frame
18 months2
ATB exposure at discharge
Duration of antibiotics prescribed at discharge
Time frame
From the date of enrolment through to the date of ICU discharge, approximately 28 days3
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
Time frame
will be measured at 24 hours (T1), day 3 (T2), day 7 (T3) and day 14 (T4) after admission4
Length of ICU stay in days
that is, length of ICU stay in days
Time frame
at 3 monthsOther outcomes
1
Composition of the oral and lower airway microbiome between groups measured by the bacterial 16S rRNA sequencing
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 142
Antibiotic Free Days
The number of days where participant did not require the use of antibiotics
Time frame
up to 30 days3
The number of participants with Non-pulmonary infections
The number of participants with Non-pulmonary infections
Time frame
up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov