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

NCT06045429 | Recruiting Phase 4

• 1 other identifier: VP/46/0/2022
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

VAP - Ventilator Associated Pneumonia

Keywords

pneumonia; hydrogen peroxide; chlorhexidine; respiratory tract microbiome

Outcome Measures

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.

  18 months

Secondary Outcomes (5)

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

  18 months

• ATB exposure at discharge

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

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

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

• Length of ICU stay in days

  at 3 months

• Number of ventilator-free days;

  at 28 days

Other Outcomes (3)

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

  day 0, day 7 and day 14

• Antibiotic Free Days

  up to 30 days

• The number of participants with Non-pulmonary infections

  up to 30 days

Study Arms (2)

Hydrogen Peroxide

EXPERIMENTAL

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).

Drug: Oroxid®

Chlorhexidine

ACTIVE COMPARATOR

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).

Drug: Chlorhexidine mouthwash

Interventions

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.

Also known as: 3% hydrogen peroxide mouthwash

Hydrogen Peroxide

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

Also known as: 0,2% chlorhexidine gluconate

Chlorhexidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

3rd Faculty of Medicine and FNKV

Prague, 11000, Czechia

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Kateřina Jiroutková, MD

  3rd Faculty of Medicine, Charles University and FNKV, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kateřina Rambousková, MD

CONTACT

+420 721 185 134; kacakoubkova@seznam.cz

Adela Jiroudkova

CONTACT

+420 602 145 168; adela.jiroudkova@ruk.cuni.cz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Kateřina Jiroutková, MD, PhD, EDAIC

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 21, 2023
• Study Start: May 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

CZ (1)