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Recruiting Phase 4 NCT06045429

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

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Trial Parameters

Condition VAP - Ventilator Associated Pneumonia
Sponsor Charles University, Czech Republic
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 160
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-05-01
Completion 2025-06
Interventions
Oroxid®Chlorhexidine mouthwash

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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.

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

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