VAP - Ventilator Associated PneumoniaPhase 4HyperMICROBENCT06045429
Oral Care With 3% Hydrogen Peroxide (Oroxid®) in ICU - Effects on the Lower Airway Microbial Colonisation
A Phase 4 study testing Oroxid® and Chlorhexidine mouthwash in people with VAP - Ventilator Associated Pneumonia, run by Charles University, Czech Republic at 1 site in Czechia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VAP - Ventilator Associated Pneumonia
- What is being tested?
- Oroxid® and Chlorhexidine mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2024to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
3rd Faculty of Medicine and FNKV
Prague, 11000
Kateřina Rambousková, +420 721 185 134, kacakoubkova@seznam.cz
Kateřina Jiroutková, MD, 724259492, katka.nova@post.cz
About this study
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
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.
Read the detailed 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
- Conditions
- VAP - Ventilator Associated Pneumonia
- Being tested
- Oroxid®, Chlorhexidine mouthwash
- Keywords
- pneumonia, hydrogen peroxide, chlorhexidine, respiratory tract microbiome
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oroxid®Drug
Also called 3% hydrogen peroxide 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 Oroxid® mouthwash.
Chlorhexidine mouthwashDrug
Also called 0,2% chlorhexidine gluconate
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Chlorhexidine mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (5)
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
Measured: 18 months
ATB exposure at discharge
Duration of antibiotics prescribed at discharge
Measured: 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.
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
Measured: 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
that is, length of ICU stay in days
Measured: at 3 months
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
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 May 2024
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VAP - Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kateřina Jiroutková, Charles University, Czech Republic
- Investigators
- Kateřina Jiroutková, MD, Principal investigator, 3rd Faculty of Medicine, Charles University and FNKV, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045429
- Sponsor's protocol ID
- VP/46/0/2022
- Acronym
- HyperMICROBE
- Status last verified
- Jul 2024
- First submitted
- 24 Aug 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06045429
- Acronym / sponsor ID
- HyperMICROBE / VP/46/0/2022
- Conditions
- VAP - Ventilator Associated Pneumonia
- Keywords
- pneumonia, hydrogen peroxide, chlorhexidine, respiratory tract microbiome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hydrogen Peroxide | Experimental | Drug: Oroxid®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). |
| Chlorhexidine | Active comparator | Drug: Chlorhexidine mouthwashControl 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oroxid®Also: 3% hydrogen peroxide mouthwashAll 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. | Drug | Hydrogen Peroxide |
| Chlorhexidine mouthwashAlso: 0,2% chlorhexidine gluconateAll 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 | Drug | 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.
Time frame: 18 months
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.
5 secondary outcomes
Differences in the relative risk of infection related ventilator associated complications (IVAC)
Time frame: 18 months
ATB exposure at discharge
Time frame: 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.
Time frame: 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
Time frame: at 3 months
Number of ventilator-free days;
Time frame: at 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kateřina Jiroutková, MD principal investigator
3rd Faculty of Medicine, Charles University and FNKV, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oroxid® and Chlorhexidine mouthwash in people with VAP - Ventilator Associated Pneumonia, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kateřina Rambousková, MD (+420 721 185 134, kacakoubkova@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of lower respiratory tract microbial colonisation analysed by Kaplan-Maier method, censored in the case of ICU discharge or extubation > 24h. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.