Clinical trial NCT06045429: Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation
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
Overall status: RECRUITING
Phase: PHASE4
Conditions: VAP - Ventilator Associated Pneumonia
Keywords: pneumonia
hydrogen peroxide
chlorhexidine
respiratory tract microbiome
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. In-patient of ICU and expected to stay \> 5 days
3. Mechanical ventilation or imminent need of it; predicted length of mechanical ventilation (MV) ≥ 72h
4. Clinical Pulmonary Infection score (CPIS) less than 6 at the baseline
5. No history and symptoms of aspiration at the baseline

Exclusion Criteria:

1. ATB therapy of respiratory infection on admission
2. Suspected pulmonary infection on admission and in the first 48h of mechanical ventilation
3. Pregnancy
4. Oral ulcers or injuries
5. Patient with a history of hydrogen peroxide allergy

Primary outcomes:
measure: Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.
timeFrame: 18 months
Secondary outcomes:
measure: Differences in the relative risk of infection related ventilator associated complications (IVAC)
timeFrame: 18 months
measure: ATB exposure at discharge
timeFrame: From the date of enrolment through to the date of ICU discharge, approximately 28 days
measure: Intraoral complications, reported using the Bedside oral exam (BOE) score, validated and adopted for ICU.
timeFrame: will be measured at 24 hours (T1), day 3 (T2), day 7 (T3) and day 14 (T4) after admission
measure: Length of ICU stay in days
timeFrame: at 3 months
measure: Number of ventilator-free days;
timeFrame: at 28 days
Other outcomes:
measure: Composition of the oral and lower airway microbiome between groups measured by the bacterial 16S rRNA sequencing
timeFrame: day 0, day 7 and day 14
measure: Antibiotic Free Days
timeFrame: up to 30 days
measure: The number of participants with Non-pulmonary infections
timeFrame: up to 30 days
Locations:
city: Praha
country: Czechia
facility: 3rd Faculty of Medicine and FNKV
Study officials:
affiliation: 3rd Faculty of Medicine, Charles University and FNKV, Prague
name: Kateřina Jiroutková, MD
role: PRINCIPAL_INVESTIGATOR
References: