Clinical trial
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
Name
VP/46/0/2022
Description
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.
Trial arms
Trial start
2024-05-01
Estimated PCD
2025-06-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Hydrogen Peroxide
Other names:
3% hydrogen peroxide 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
Arms:
Chlorhexidine
Other names:
0,2% chlorhexidine gluconate
Size
160
Primary endpoint
Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h.
18 months
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 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "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.", 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2024-04-30
1 organization
Organization
Charles University