RecruitingPhase 4

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

Czechia160 participantsStarted 2024-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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

Trial details

NCT IDNCT06045429

SponsorCharles University, Czech Republic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

Contact for this trial

Kateřina Rambousková, MD

+420 721 185 134 kacakoubkova@seznam.cz

View on ClinicalTrials.gov More VAP - Ventilator Associated Pneumonia trials