Pneumonia, Ventilator-AssociatedNCT04839653
Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria
A study testing Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h, Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h and Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd in people with Pneumonia, Ventilator-Associated and Pneumonia, run by MEDSI Clinical Hospital 1, ICU at 1 site in Russia.
Trial summary
Secondary infections remain a major cause of mortality in critically ill patients, mainly because of high prevalence of multidrug-resistant microorganisms. Therefore strategies aimed to reduce the incidence of ventilator-associated pneumoniae (VAP) and bloodstream infections are of utmost important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Pneumonia, Bloodstream Infection
- What is being tested?
- Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h, Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h and Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2021to Apr 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
- Patients with expected MV for more than 24 hours
Who cannot join
- Moribund condition and expected death within 24 hours
- Malignancy (excluding primary CNS tumors)
- Patients transferred from other hospitals who were mechanically ventilated for more than 24 hours (including NIV)
Trial locations and contacts
1 site in 1 country.
Armen Oganesyan, MD contact
Russia1 site, 1 recruiting
- Recruiting
MEDSI Clinical Hospital 1
Moscow, 143442
Armen Oganesyan, oganesyan.av@medsigroup.ru
Yury Surovoy, ysurovoy@gmail.co
About this study
Official title: Efficacy and Safety of Selective Digestive Decontamination in the ICU With Rates of Antibiotic-resistant Bacteria
Secondary infections remain a major cause of mortality in critically ill patients, mainly because of high prevalence of multidrug-resistant microorganisms. Therefore strategies aimed to reduce the incidence of ventilator-associated pneumoniae (VAP) and bloodstream infections are of utmost important. There is robust data on selective digestive decontamination (SDD) efficacy in reduction of secondary infections in intensive care units (ICU) with low rates of antibacterial resistance. However the data received from hospitals with moderate-to-high rates of resistance is equivocal.
This as an interventional parallel open-label study investigating the effect of selective digestive decontamination on the rates of ventilator-associated pneumonia in critically ill patients admitted to the ICU with high prevalence of drug-resistant bacteria. Secondary outcomes include rates of bloodstream infections, mortality, duration of mechanical ventilation, duration of ICU stay, resistance selection and overall antibiotic consumption.
Read the detailed description
Single-center prospective interventional parallel study. During the first period of the study patients will receive standard therapy. During the second period the SDD protocol will be implemented in addition to the standard care. The first period will end at the moment of the last admitted patient ICU discharge or death.
Study population: general ICU adult patients anticipated to receive prolonged mechanical ventilation (more than 48 hours). Patients who are terminally ill and are anticipated to die in the next 24 hours will be excluded, so are patients with malignancies (except for patients with primary central nervous system tumors who received radical treatment) and patients admitted from other hospitals who received mechanical ventilation (including non-invasive ventilation) for more than 24 hours.
Patients in the interventional arm will receive the following SDD protocol:
- Oral paste (0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B/500000 U of nistatin q6h
- In the nasogastric tube (NGT) 10 ml of suspension containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B/8000000 U of nistatin and 500 mg of vancomycin q6h
- A 3-day course of intravenous cefotaxime 1 g q6h/ceftriaxone 1 qd
Statistical considerations and recruitment plant: VAP incidence in the ICU with high rates of antibacterial resistance is 16,7 event per 1000 days of MV. To reveal a 25% decrease of VAP events (power 80%, p < 0,05) the study should recruit 25 patients in each group. However because of the poor prognosis in mechanically ventilated elderly patients especially in the setting of acute respiratory distress syndrome the goal is to recruit in each arm at least 25 patients younger than 65 years.
- Conditions
- Pneumonia, Ventilator-Associated, Pneumonia, Bloodstream Infection, Sepsis, Respiratory Distress Syndrome, Respiratory Tract Infections
- Being tested
- Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h, Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h, Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd
- Keywords
- Pneumonia, Ventilator-Associated Pneumonia, Selective Digestive Decontamination, Secondary Infections, Infection prophylaxis, Bloodstream Infection
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia, Sepsis, Respiratory Distress Syndrome, Respiratory Tract Infections, Critical Illness, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6hDrug
Also called Polymyxin B, Gentamycin, Amphotericine B, Nistatin
The oral paste will be applied topically on the oropharyngeal mucosa q6h.
Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6hDrug
Also called Polymyxin B, Gentamycin, Amphotericine B, Vancomycine, Nistatin
The suspension will be administered through the nasogastric tube q6h.
Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qdDrug
Also called Cefotaxime, Ceftriaxone
Patients who do not receive systemic antibiotics for other reasons will get a short course of systemic antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Control group: standard care | No intervention | Patients in the standard care group will be prospectively evaluated to determine pre-defined clinical outcomes. |
| Selective digestive decontamination group | Experimental | 1. Oral paste (0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B q6h
2. In the NGT 10 ml of suspension containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B and 500 mg of vancomycin q6h
3. A 3-day course of intravenous cefotaxime 1 g q6h/ceftriaxone 1 qd Receives: Drug: Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h; Drug: Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h; Drug: Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of ventilator-associated pneumonia
Number of ventilator-associated pneumonia events per 1000 days of MV
Measured: During ICU stay up to 28 days
Secondary outcomes (6)
The incidence of bloodstream infections
Number of bloodstream infection events per 1000 days of ICU stay
Measured: During ICU stay up to 28 days
ICU mortality
All-cause mortality
Measured: During ICU stay up to 28 days
Duration of mechanical ventilation
The duration that the patient receives mechanical ventilation in the ICU
Measured: During ICU stay up to 28 days
Duration of organ support
The duration that the patient receives mechanical ventilation, vasopressor infusion or renal-replacement therapy
Measured: During ICU stay up to 28 days
Antimicrobial drug consumption
Average antimicrobial drug consumption (as daily defined doses) per patient stay
Measured: During ICU stay up to 28 days
Antimicrobial resistance selection
The magnitude of antimicrobial resistance selection in terms of resistant microorganisms prevalence and whole burden of AMR genes
Measured: During ICU stay up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 May 2021
- Primary completionApr 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- During the first period patients will receive standard care. During the second period SDD protocol will be implemented.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MEDSI Clinical Hospital 1, ICU
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yury Surovoy, MEDSI Clinical Hospital 1, ICU
- Investigators
- Dmitry Azovskiy, MD, phD, Principal investigator, MEDSI Clinical Hospital 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839653
- Sponsor's protocol ID
- SDDMEDSI2021
- Status last verified
- Jun 2021
- First submitted
- 5 Apr 2021
- Last updated
- 8 Jun 2021
- 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Selective Digestive Decontamination in the ICU With Rates of Antibiotic-resistant Bacteria
- ClinicalTrials.gov ID
- NCT04839653
- Acronym / sponsor ID
- SDDMEDSI2021
- Conditions
- Pneumonia, Ventilator-Associated, Pneumonia, Bloodstream Infection, Sepsis, Respiratory Distress Syndrome, Respiratory Tract Infections
- Keywords
- Pneumonia, Ventilator-Associated Pneumonia, Selective Digestive Decontamination, Secondary Infections, Infection prophylaxis, Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MEDSI Clinical Hospital 1, ICUUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 9 Apr 2021 (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.
Secondary infections remain a major cause of mortality in critically ill patients, mainly because of high prevalence of multidrug-resistant microorganisms. Therefore strategies aimed to reduce the incidence of ventilator-associated pneumoniae (VAP) and bloodstream infections are of utmost important. There is robust data on selective digestive decontamination (SDD) efficacy in reduction of secondary infections in intensive care units (ICU) with low rates of antibacterial resistance. However the data received from hospitals with moderate-to-high rates of resistance is equivocal.
This as an interventional parallel open-label study investigating the effect of selective digestive decontamination on the rates of ventilator-associated pneumonia in critically ill patients admitted to the ICU with high prevalence of drug-resistant bacteria. Secondary outcomes include rates of bloodstream infections, mortality, duration of mechanical ventilation, duration of ICU stay, resistance selection and overall antibiotic consumption.
Detailed description
Single-center prospective interventional parallel study. During the first period of the study patients will receive standard therapy. During the second period the SDD protocol will be implemented in addition to the standard care. The first period will end at the moment of the last admitted patient ICU discharge or death.
Study population: general ICU adult patients anticipated to receive prolonged mechanical ventilation (more than 48 hours). Patients who are terminally ill and are anticipated to die in the next 24 hours will be excluded, so are patients with malignancies (except for patients with primary central nervous system tumors who received radical treatment) and patients admitted from other hospitals who received mechanical ventilation (including non-invasive ventilation) for more than 24 hours.
Patients in the interventional arm will receive the following SDD protocol:
- Oral paste (0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B/500000 U of nistatin q6h
- In the nasogastric tube (NGT) 10 ml of suspension containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B/8000000 U of nistatin and 500 mg of vancomycin q6h
- A 3-day course of intravenous cefotaxime 1 g q6h/ceftriaxone 1 qd
Statistical considerations and recruitment plant: VAP incidence in the ICU with high rates of antibacterial resistance is 16,7 event per 1000 days of MV. To reveal a 25% decrease of VAP events (power 80%, p < 0,05) the study should recruit 25 patients in each group. However because of the poor prognosis in mechanically ventilated elderly patients especially in the setting of acute respiratory distress syndrome the goal is to recruit in each arm at least 25 patients younger than 65 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During the first period patients will receive standard care. During the second period SDD protocol will be implemented.
| Arm | Type | Receives |
|---|---|---|
| Control group: standard care | No intervention | –Patients in the standard care group will be prospectively evaluated to determine pre-defined clinical outcomes. |
| Selective digestive decontamination group | Experimental | Drug: Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h, Drug: Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h, Drug: Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd1. Oral paste (0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B q6h 2. In the NGT 10 ml of suspension containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B and 500 mg of vancomycin q6h 3. A 3-day course of intravenous cefotaxime 1 g q6h/ceftriaxone 1 qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with expected MV for more than 24 hours
Key exclusion criteria (3 listed)
- Moribund condition and expected death within 24 hours
- Malignancy (excluding primary CNS tumors)
- Patients transferred from other hospitals who were mechanically ventilated for more than 24 hours (including NIV)
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 |
|---|---|---|
| Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6hAlso: Polymyxin B, Gentamycin, Amphotericine B, NistatinThe oral paste will be applied topically on the oropharyngeal mucosa q6h. | Drug | Selective digestive decontamination group |
| Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6hAlso: Polymyxin B, Gentamycin, Amphotericine B, Vancomycine, NistatinThe suspension will be administered through the nasogastric tube q6h. | Drug | Selective digestive decontamination group |
| Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qdAlso: Cefotaxime, CeftriaxonePatients who do not receive systemic antibiotics for other reasons will get a short course of systemic antibiotic | Drug | Selective digestive decontamination group |
Primary outcome
The incidence of ventilator-associated pneumonia
Time frame: During ICU stay up to 28 days
Number of ventilator-associated pneumonia events per 1000 days of MV
6 secondary outcomes
The incidence of bloodstream infections
Time frame: During ICU stay up to 28 days
ICU mortality
Time frame: During ICU stay up to 28 days
Duration of mechanical ventilation
Time frame: During ICU stay up to 28 days
Duration of organ support
Time frame: During ICU stay up to 28 days
Antimicrobial drug consumption
Time frame: During ICU stay up to 28 days
Antimicrobial resistance selection
Time frame: During ICU stay up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
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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.
Armen Oganesyan, MD contact
Dmitry Azovskiy, MD, phD principal investigator
MEDSI Clinical Hospital 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h, Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h and Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd in people with Pneumonia, Ventilator-Associated and Pneumonia, run by MEDSI Clinical Hospital 1, ICU 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 3 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 8 Jun 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yury Surovoy, MD (+79166911507, ysurovoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of ventilator-associated pneumonia (time frame: During ICU stay up to 28 days). 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 Jun 2021.