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

VAP - Ventilator Associated Pneumonia Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06045429
• Other study ID #: VP/46/0/2022
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• VAP - Ventilator Associated Pneumonia

Intervention

Drug:
• Oroxid®
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.
• Chlorhexidine mouthwash
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	day 0, day 7 and day 14
Other	Antibiotic Free Days	The number of days where participant did not require the use of antibiotics	up to 30 days
Other	The number of participants with Non-pulmonary infections	The number of participants with Non-pulmonary infections	up to 30 days
Primary	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	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	18 months
Secondary	ATB exposure at discharge	Duration of antibiotics prescribed at discharge	From the date of enrolment through to the date of ICU discharge, approximately 28 days
Secondary	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	will be measured at 24 hours (T1), day 3 (T2), day 7 (T3) and day 14 (T4) after admission
Secondary	Length of ICU stay in days	that is, length of ICU stay in days	at 3 months
Secondary	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	at 28 days