Trauma InjurySGDC-VAPNCT04325685
The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia
A study testing Antiseptic Solution and Bacteriophage in people with Trauma Injury and Brain Injuries, run by Northern State Medical University at 1 site in Russia.
Trial summary
Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Injury, Brain Injuries, Abdominal Sepsis
- What is being tested?
- Antiseptic Solution and Bacteriophage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2020to 7 Nov 2023
- Phase
- Interventional
- 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
- invasive mechanical ventilation beyond 48 hours
Who cannot join
- hospital - acquired pneumonia
- community - acquired pneumoniae
- BMI > 35 kg/cm2
- pregnancy
- tracheostomy
- reintubation
Trial locations and contacts
1 site in 1 country.
Russia1 site
Budgetary Healthcare Institution of Arkhangelsk Region "Severodvinsk City Clinical Emergency Hospital # 2"
Severodvinsk, Arkhangelskaya oblast, 164500
About this study
Official title: The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia and Associated Microbiomes.
Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).
- Conditions
- Trauma Injury, Brain Injuries, Abdominal Sepsis, Pancreatitis, Meningitis, Encephalitis
- Being tested
- Control, Antiseptic Solution, Bacteriophage
- Medical subject headings
- Accidental Injuries, Brain Injuries, Intraabdominal Infections, Pancreatitis, Meningitis, Encephalitis, Seizures, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDrug
Also called Saline
Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
Antiseptic SolutionDrug
Also called Octenisept
Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
BacteriophageDrug
Also called Sextaphag
Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Drug: Control |
| Antiseptic (Octenisept) group | Active comparator | Not described Receives: Drug: Antiseptic Solution |
| Bacteriophage (Sextaphag) group | Experimental | Not described Receives: Drug: Bacteriophage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator-associated pneumonia (VAP)
CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed
Measured: Change from Baseline CPIS at 14 days
Changing of oral and lung microbiomes
Microbiology researching samples from oral cavity and trachea. The Gram positive and Gram negative aerobes and anaerobes will be assessed with observing Colony Form Unit
Measured: Change from Baseline Microbiology researching at 14 days
Secondary outcomes (4)
Organ dysfunction
Sequential Organ Function Assessment (SOFA) will be using for assessment organ dysfunction Patient examination with Sequential Organ Function Assessment (SOFA). If Sequential Organ Function Assessment more then 2 points Organ dysfunction is present. The hirher value is equal worse outcome
Measured: Change from Baseline Sequential Organ Function Assessment at 14 days
Concentration of C - reactive protein (CRP)
Biomarker of the VAP
Measured: Change from Baseline CRP at 14 days
Concentration of Procalcitonin (PCT)
Biomarker of the VAP
Measured: Change from Baseline PCT at 14 days
Rate of Mortality
Mortality for 28 days of a hospitalization
Measured: Change from Baseline PCT 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 posted27 Mar 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vsevolod V. Kuzkov, Northern State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325685
- Sponsor's protocol ID
- SGDC-VAP-1
- Acronym
- SGDC-VAP
- Status last verified
- Nov 2023
- First submitted
- 26 Mar 2020
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia and Associated Microbiomes.
- ClinicalTrials.gov ID
- NCT04325685
- Acronym / sponsor ID
- SGDC-VAP / SGDC-VAP-1
- Conditions
- Trauma Injury, Brain Injuries, Abdominal Sepsis, Pancreatitis, Meningitis, Encephalitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northern State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 27 Mar 2020 (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.
Oropharynx is the main source of pathogen microorganisms for the ventilator - associated pneumoniae. As known bacteriophages can eliminate different pathogen microorganisms or reduce a degree of a pathogen's colonization. The research team is considering that oropharyngeal decontamination with bacteriophages can prevent the developing of the ventilator - associated pneumoniae. There will be three groups in this investigation: placebo, antiseptic drug (Octenisept) and bacteriophage (Sexthaphag).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Control |
| Antiseptic (Octenisept) group | Active comparator | Drug: Antiseptic Solution |
| Bacteriophage (Sextaphag) group | Experimental | Drug: Bacteriophage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- invasive mechanical ventilation beyond 48 hours
Key exclusion criteria (6 listed)
- hospital - acquired pneumonia
- community - acquired pneumoniae
- BMI > 35 kg/cm2
- pregnancy
- tracheostomy
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 |
|---|---|---|
| ControlAlso: SalineOropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation | Drug | Control group |
| Antiseptic SolutionAlso: OcteniseptOropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation | Drug | Antiseptic (Octenisept) group |
| BacteriophageAlso: SextaphagOropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation | Drug | Bacteriophage (Sextaphag) group |
Primary outcome
Incidence of ventilator-associated pneumonia (VAP)
Time frame: Change from Baseline CPIS at 14 days
CPIS is using for diagnosis the VAP, if CPIS equal or more 6, the VAP will be confirmed
Changing of oral and lung microbiomes
Time frame: Change from Baseline Microbiology researching at 14 days
Microbiology researching samples from oral cavity and trachea. The Gram positive and Gram negative aerobes and anaerobes will be assessed with observing Colony Form Unit
4 secondary outcomes
Organ dysfunction
Time frame: Change from Baseline Sequential Organ Function Assessment at 14 days
Concentration of C - reactive protein (CRP)
Time frame: Change from Baseline CRP at 14 days
Concentration of Procalcitonin (PCT)
Time frame: Change from Baseline PCT at 14 days
Rate of Mortality
Time frame: Change from Baseline PCT at 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antiseptic Solution and Bacteriophage in people with Trauma Injury and Brain Injuries, run by Northern State Medical University at 1 site in Russia.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 8 Nov 2023. 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 Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator-associated pneumonia (VAP) (time frame: Change from Baseline CPIS at 14 days). The study lists 2 primary outcomes in all. 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 8 Nov 2023.