Ventilator Associated PneumoniaNCT03074552
Probiotic Prophylaxis for Microbiome Modulation and VAP or Infections Prevention in Multitrauma Patients
A study testing LactoLevure in people with Ventilator Associated Pneumonia and Infection, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
Ventilator-associated pneumonia (VAP), is a type of pneumonia that develops more than 48 hours after endotracheal intubation, is common in intensive care units (ICUs). It is estimated to be responsible for 27% to 47% of ICU-acquired infections. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventilator Associated Pneumonia, Infection, Trauma
- What is being tested?
- LactoLevure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteGreece
- Study dates
- 19 Aug 2017to 15 Dec 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults >18 and < 80 years oldmultitrauma patients with at least two organ-system injury
- intubated immediately after injury
- likelihood that the patient would require mechanical ventilation with an endotracheal tube (or tracheostomy) for >10 days
- life expectancy > 15 days
Who cannot join
- investigators unable to obtain informed written consent from patients' relatives
- administer the first dose of the study drug within 24 hours of intubation
- pregnancy; lactation; immunosuppression; hematologic disease; prosthetic cardiac valve or vascular graft; cardiac trauma; history of rheumatic fever, endocarditis, or congenital cardiac abnormality; oropharyngeal mucosal injury; recent history of sinusitis and respiratory tract infection
- obesity [BMI > 40]
- administration of antibiotics for > 3 days before recruitment into the study
- administration of probiotics before recruitment into the study
- history of infection from Hepatis B or C and HIV
- administration of < 90% of the predicted doses of probiotics during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotic Prophylaxis for Microbiome Modulation and Ventilator Associated Pneumonia (VAP) or Severe Infections Prevention in Multitrauma Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Ventilator-associated pneumonia (VAP), is a type of pneumonia that develops more than 48 hours after endotracheal intubation, is common in intensive care units (ICUs). It is estimated to be responsible for 27% to 47% of ICU-acquired infections.
The pathogenesis of VAP is complex but typically involves colonization of the aerodigestive tract with pathogenic bacteria, the formation of biofilms, and microaspiration of contaminated secretions. Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of VAP. One novel intervention is the administration of prophylactic probiotics which restore non-pathogenic flora that compete with pathogens, modulate local and systemic immunity, and decrease intestinal permeability and thus can be beneficial in preventing nosocomial infections in critically ill patients. The role of the probiotics in preventing VAP in mechanically ventilated patients is inconclusive. Some evidence indicates that probiotics may reduce the incidence of VAP by inhibiting pathogen adhesion, improving gut mucosal barrier function, reducing bacterial translocation and up-regulating the immune system. Furthermore, guidelines remain inconclusive regarding the role of commensal oropharyngeal flora (COF) as a causative agent in VAP, mainly due to a scarcity of studies in this research field. However, there is evidence that COF may cause pulmonary infection, mostly in immunocompromised patients.
Read the detailed description
The oropharyngeal swab will be collected on days 1, 3 and 7 after ICU admission and upon the occurrence of VAP or other infection. Nonbronchoscopic bronchoalveolar lavage (BAL) using a protected catheter will be collected on day 3 after ICU admission and upon the occurrence of VAP. Whole blood sample and stool sample will be collected on day 1 after ICU admission and upon the occurrence of VAP or other infection for microbiome analysis.
As soon as the first sample of the oropharyngeal swab is collected, patients will be allocated to the "treatment" groups. Each patient will receive two capsules per day for 15 consecutive days post admission. The content of one capsule will be suspended in 100ml tap water and administered by nasogastric tube or through), while the content of the other capsule will be suspended in sterile, water-based surgical lubricant and administered as a slurry to the oropharynx. The administration will be performed by a study nurse who was responsible for ascertaining that the whole prepared volume is given.
The study protocol-mandated baseline data will include demographic information, medical history, and the APACHE II, SAPS II, NISS and SOFA score, and Operative POSSUM score (only cases undergoing surgical treatment).
Additional information collected on a daily basis will include patient's clinical course with special emphasis on clinical signs of VAP or infections, type of chemoprophylaxis, endotracheal or tracheostomy tube cuff pressure, type of nutrition and bowel movement. Furthermore, duration of intubation, tracheostomy day after ICU admission, duration of mechanical ventilation, lengths of stay in the ICU and hospital, adverse events (related and non-related to probiotics administration) and mortality. Data recording will be extended up to 30 days after hospital admission (patient recovered, treated in ICU / department or death).
Central venous line infection will be considered as positive when there is bacteremia with common skin commensal and positive catheter tip culture or exit site culture for the same organism.
An ICU-acquired urinary tract infection will be deemed present if there are at least 103 colony-forming units (cfu)/mL of 1 or 2 micro-organisms identified by urine culture in patients who develop a positive urine culture first identified 48 h or later after ICU admission.
A superficial incisional infection (SSI) must meet the following criterion:
Infection occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the incision and patient has at least 1 of the following:
- purulent drainage from the superficial incision
- organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
- at least 1 of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat, and superficial incision is deliberately opened by the surgeon and is culture positive or not cultured. A culture-negative finding does not meet this criterion.
- diagnosis of superficial incisional SSI by the surgeon or attending physician.
Intraabdominal trauma infection will be defined by the following:
- Temperature >38°C or <36°C
- White blood cell count >12 000/mm3 or <4000/mm3 or >10% immature bands
- Abdominal tenderness during clinical examination
- CT scanning compatible with positive findings for acute intraabdominal infection An antibiotics-related infection will be documented by the detection of toxins produced by C. difficile bacteria in a stool sample.
Bacteremia will be defined as the presence of a recognized Gram(+) or Gram(-) pathogen or Candida spp cultured from one or more blood cultures and organism cultured from blood is not related to an infection at another site Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
Organ dysfunction will be identified as an acute change in total SOFA score ≥2 points consequent to the infection.
Patients with septic shock will be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation.
- Conditions
- Ventilator Associated Pneumonia, Infection, Trauma
- Being tested
- LactoLevure, Placebo
- Keywords
- probiotics, VAP, microbiome, trauma, infections
- Medical subject headings
- Pneumonia, Ventilator-Associated, Infections, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoLevureDietary supplement
The probiotic preparation will consist a combination of four probiotics: Lactobacillus acidophilus LA-5 1.75 × 109 CFU, Lactobacillus Plantarum 0.5 × 109 CFU, Bifidobacterium lactis BB-12 1.75 × 109 CFU και Saccharomyces boulardii 1.5 × 109 CFU per capsule (LactoLevure, UniPharma, Athens, Greece).
PlaceboOther
Placebo will consist of identical capsules of powdered glucose polymer
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | The probiotic preparation [ LactoLevure] will consist a combination of four probiotics. Receives: Dietary Supplement: LactoLevure |
| Placebo | Placebo comparator | Placebo will consist of identical capsules of powdered glucose polymer, and they will be constructed by the same industry that manufactures the probiotics capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probiotics for VAP prophylaxis
To determine the efficacy of probiotic administration for the prophylaxis of VAP in a multi trauma population admitted in the ICU This outcome will be assessed by the difference of number of cases (n) and percentage of change (%) in VAP development between probiotics and control groups
Ventilator associated pneumonia (VAP) will be defined as pneumonia developing more than 48 h after endotracheal intubation and initiation of mechanical ventilation. The diagnostic criteria for VAP will be the following:
- SOFA score elevation of at least 1 point
- New or progressive radiographic consolidation or infiltrate. In addition, at least 2 of the following:
- Temperature > 38 °C
- Leukocytosis (white blood cell count ≥ 12,000 cells/ mm3) or leukopenia (white blood cell count < 4,000 cells/mm3)
- Presence of purulent secretions
- BAL > 104 colony forming units (CFU)/ml)
Measured: 30 days
Secondary outcomes (2)
Probiotics for indections control
The efficacy of probiotics for controlling infections related to trauma, urinary tract, central venous line or related to antibiotics use.
This outcome will be assessed by the difference of number of cases (n) and percentage of change (%) in infections other than VAP between probiotics and control groups [The criteria for documentation of the above-mentioned infections are provided in more detail in the Detailed Description section]
Measured: 30 days
Probiotics for bacteremia, sepsis or septic shock reduction
The efficacy of the use of probiotics for reducing the incidence of bacteremia, sepsis or septic shock.
This outcome will be assessed by the difference of number of cases (n) and percentage of change (%) in bacteremia, sepsis or septic shock between probiotics and control groups [The criteria for documentation of the above-mentioned infections are provided in more detail in the Detailed Description section].
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start19 Aug 2017
- Primary completion15 Nov 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study will be a multicenter, randomized, double-blind, placebo-controlled trial including data collected from 9 ICUs. Patients will be randomly assigned in a 1:1 ratio to receive probiotic or placebo treatment according to a computer-based table blinded to study investigators and physicians in charge.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Uni-Pharma
- Responsible party
- Principal investigator, Georgia Tsaousi, Aristotle University Of Thessaloniki
- Investigators
- Katerina Kotzampassi, MD, PhD, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074552
- Sponsor's protocol ID
- ProVAP
- Status last verified
- Aug 2021
- First submitted
- 25 Feb 2017
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scholte JB, van der Velde JI, Linssen CF, van Dessel HA, Bergmans DC, Savelkoul PH, Roekaerts PM, van Mook WN. Ventilator-associated Pneumonia caused by commensal oropharyngeal Flora; [corrected] a retrospective Analysis of a prospectively collected Database. BMC Pulm Med. 2015 Aug 12;15:86. doi: 10.1186/s12890-015-0087-y.
PubMed 26264828Wang J, Liu KX, Ariani F, Tao LL, Zhang J, Qu JM. Probiotics for preventing ventilator-associated pneumonia: a systematic review and meta-analysis of high-quality randomized controlled trials. PLoS One. 2013 Dec 18;8(12):e83934. doi: 10.1371/journal.pone.0083934. eCollection 2013.
PubMed 24367620Zeng J, Wang CT, Zhang FS, Qi F, Wang SF, Ma S, Wu TJ, Tian H, Tian ZT, Zhang SL, Qu Y, Liu LY, Li YZ, Cui S, Zhao HL, Du QS, Ma Z, Li CH, Li Y, Si M, Chu YF, Meng M, Ren HS, Zhang JC, Jiang JJ, Ding M, Wang YP. Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial. Intensive Care Med. 2016 Jun;42(6):1018-28. doi: 10.1007/s00134-016-4303-x. Epub 2016 Apr 4.
PubMed 27043237Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.
PubMed 26903336Kotzampassi K, Giamarellos-Bourboulis EJ. Probiotics for infectious diseases: more drugs, less dietary supplementation. Int J Antimicrob Agents. 2012 Oct;40(4):288-96. doi: 10.1016/j.ijantimicag.2012.06.006. Epub 2012 Aug 2.
PubMed 22858373Stavrou G, Giamarellos-Bourboulis EJ, Kotzampassi K. The role of probiotics in the prevention of severe infections following abdominal surgery. Int J Antimicrob Agents. 2015 Dec;46 Suppl 1:S2-4. doi: 10.1016/j.ijantimicag.2015.10.003.
PubMed 26686273Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.
PubMed 25894405Giamarellos-Bourboulis EJ, Bengmark S, Kanellakopoulou K, Kotzampassi K. Pro- and synbiotics to control inflammation and infection in patients with multiple injuries. J Trauma. 2009 Oct;67(4):815-21. doi: 10.1097/TA.0b013e31819d979e.
PubMed 19820590
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Prophylaxis for Microbiome Modulation and Ventilator Associated Pneumonia (VAP) or Severe Infections Prevention in Multitrauma Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03074552
- Acronym / sponsor ID
- ProVAP
- Conditions
- Ventilator Associated Pneumonia, Infection, Trauma
- Keywords
- probiotics, VAP, microbiome, trauma, infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Uni-Pharma
- Study start
- 19 Aug 2017 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 9 Mar 2017 (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.
Ventilator-associated pneumonia (VAP), is a type of pneumonia that develops more than 48 hours after endotracheal intubation, is common in intensive care units (ICUs). It is estimated to be responsible for 27% to 47% of ICU-acquired infections.
The pathogenesis of VAP is complex but typically involves colonization of the aerodigestive tract with pathogenic bacteria, the formation of biofilms, and microaspiration of contaminated secretions. Preventing carriage of potentially pathogenic micro-organisms from the aerodigestive tract is an infection control strategy used to reduce the occurrence of VAP. One novel intervention is the administration of prophylactic probiotics which restore non-pathogenic flora that compete with pathogens, modulate local and systemic immunity, and decrease intestinal permeability and thus can be beneficial in preventing nosocomial infections in critically ill patients. The role of the probiotics in preventing VAP in mechanically ventilated patients is inconclusive. Some evidence indicates that probiotics may reduce the incidence of VAP by inhibiting pathogen adhesion, improving gut mucosal barrier function, reducing bacterial translocation and up-regulating the immune system. Furthermore, guidelines remain inconclusive regarding the role of commensal oropharyngeal flora (COF) as a causative agent in VAP, mainly due to a scarcity of studies in this research field. However, there is evidence that COF may cause pulmonary infection, mostly in immunocompromised patients.
Detailed description
The oropharyngeal swab will be collected on days 1, 3 and 7 after ICU admission and upon the occurrence of VAP or other infection. Nonbronchoscopic bronchoalveolar lavage (BAL) using a protected catheter will be collected on day 3 after ICU admission and upon the occurrence of VAP. Whole blood sample and stool sample will be collected on day 1 after ICU admission and upon the occurrence of VAP or other infection for microbiome analysis.
As soon as the first sample of the oropharyngeal swab is collected, patients will be allocated to the "treatment" groups. Each patient will receive two capsules per day for 15 consecutive days post admission. The content of one capsule will be suspended in 100ml tap water and administered by nasogastric tube or through), while the content of the other capsule will be suspended in sterile, water-based surgical lubricant and administered as a slurry to the oropharynx. The administration will be performed by a study nurse who was responsible for ascertaining that the whole prepared volume is given.
The study protocol-mandated baseline data will include demographic information, medical history, and the APACHE II, SAPS II, NISS and SOFA score, and Operative POSSUM score (only cases undergoing surgical treatment).
Additional information collected on a daily basis will include patient's clinical course with special emphasis on clinical signs of VAP or infections, type of chemoprophylaxis, endotracheal or tracheostomy tube cuff pressure, type of nutrition and bowel movement. Furthermore, duration of intubation, tracheostomy day after ICU admission, duration of mechanical ventilation, lengths of stay in the ICU and hospital, adverse events (related and non-related to probiotics administration) and mortality. Data recording will be extended up to 30 days after hospital admission (patient recovered, treated in ICU / department or death).
Central venous line infection will be considered as positive when there is bacteremia with common skin commensal and positive catheter tip culture or exit site culture for the same organism.
An ICU-acquired urinary tract infection will be deemed present if there are at least 103 colony-forming units (cfu)/mL of 1 or 2 micro-organisms identified by urine culture in patients who develop a positive urine culture first identified 48 h or later after ICU admission.
A superficial incisional infection (SSI) must meet the following criterion:
Infection occurs within 30 days after the operative procedure and involves only skin and subcutaneous tissue of the incision and patient has at least 1 of the following:
- purulent drainage from the superficial incision
- organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
- at least 1 of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat, and superficial incision is deliberately opened by the surgeon and is culture positive or not cultured. A culture-negative finding does not meet this criterion.
- diagnosis of superficial incisional SSI by the surgeon or attending physician.
Intraabdominal trauma infection will be defined by the following:
- Temperature >38°C or <36°C
- White blood cell count >12 000/mm3 or <4000/mm3 or >10% immature bands
- Abdominal tenderness during clinical examination
- CT scanning compatible with positive findings for acute intraabdominal infection An antibiotics-related infection will be documented by the detection of toxins produced by C. difficile bacteria in a stool sample.
Bacteremia will be defined as the presence of a recognized Gram(+) or Gram(-) pathogen or Candida spp cultured from one or more blood cultures and organism cultured from blood is not related to an infection at another site Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
Organ dysfunction will be identified as an acute change in total SOFA score ≥2 points consequent to the infection.
Patients with septic shock will be identified with a clinical construct of sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18mg/dL) despite adequate volume resuscitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study will be a multicenter, randomized, double-blind, placebo-controlled trial including data collected from 9 ICUs. Patients will be randomly assigned in a 1:1 ratio to receive probiotic or placebo treatment according to a computer-based table blinded to study investigators and physicians in charge.
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: LactoLevureThe probiotic preparation [ LactoLevure] will consist a combination of four probiotics. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will consist of identical capsules of powdered glucose polymer, and they will be constructed by the same industry that manufactures the probiotics capsules. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults >18 and < 80 years oldmultitrauma patients with at least two organ-system injury
- intubated immediately after injury
- likelihood that the patient would require mechanical ventilation with an endotracheal tube (or tracheostomy) for >10 days
- life expectancy > 15 days
Key exclusion criteria (8 listed)
- investigators unable to obtain informed written consent from patients' relatives
- administer the first dose of the study drug within 24 hours of intubation
- pregnancy; lactation; immunosuppression; hematologic disease; prosthetic cardiac valve or vascular graft; cardiac trauma; history of rheumatic fever, endocarditis, or congenital cardiac abnormality; oropharyngeal mucosal injury; recent history of sinusitis and respiratory tract infection
- obesity [BMI > 40]
- administration of antibiotics for > 3 days before recruitment into the study
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 |
|---|---|---|
| LactoLevureThe probiotic preparation will consist a combination of four probiotics: Lactobacillus acidophilus LA-5 1.75 × 109 CFU, Lactobacillus Plantarum 0.5 × 109 CFU, Bifidobacterium lactis BB-12 1.75 × 109 CFU και Saccharomyces boulardii 1.5 × 109 CFU per capsule (LactoLevure, UniPharma, Athens, Greece). | Dietary supplement | Probiotics |
| PlaceboPlacebo will consist of identical capsules of powdered glucose polymer | Other | Placebo |
Primary outcome
Probiotics for VAP prophylaxis
Time frame: 30 days
To determine the efficacy of probiotic administration for the prophylaxis of VAP in a multi trauma population admitted in the ICU This outcome will be assessed by the difference of number of cases (n) and percentage of change (%) in VAP development between probiotics and control groups Ventilator associated pneumonia (VAP) will be defined as pneumonia developing more than 48 h after endotracheal intubation and initiation of mechanical ventilation. The diagnostic criteria for VAP will be the following: * SOFA score elevation of at least 1 point * New or progressive radiographic consolidation or infiltrate. In addition, at least 2 of the following: * Temperature > 38 °C * Leukocytosis (white blood cell count ≥ 12,000 cells/ mm3) or leukopenia (white blood cell count < 4,000 cells/mm3) * Presence of purulent secretions * BAL > 104 colony forming units (CFU)/ml)
2 secondary outcomes
Probiotics for indections control
Time frame: 30 days
Probiotics for bacteremia, sepsis or septic shock reduction
Time frame: 30 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 31 Aug 2021.
- Background: PubMed 26264828Scholte JB, van der Velde JI, Linssen CF, van Dessel HA, Bergmans DC, Savelkoul PH, Roekaerts PM, van Mook WN. Ventilator-associated Pneumonia caused by commensal oropharyngeal Flora; [corrected] a retrospective Analysis of a prospectively collected Database. BMC Pulm Med. 2015 Aug 12;15:86. doi: 10.1186/s12890-015-0087-y.
- Background: PubMed 24367620Wang J, Liu KX, Ariani F, Tao LL, Zhang J, Qu JM. Probiotics for preventing ventilator-associated pneumonia: a systematic review and meta-analysis of high-quality randomized controlled trials. PLoS One. 2013 Dec 18;8(12):e83934. doi: 10.1371/journal.pone.0083934. eCollection 2013.
- Background: PubMed 27043237Zeng J, Wang CT, Zhang FS, Qi F, Wang SF, Ma S, Wu TJ, Tian H, Tian ZT, Zhang SL, Qu Y, Liu LY, Li YZ, Cui S, Zhao HL, Du QS, Ma Z, Li CH, Li Y, Si M, Chu YF, Meng M, Ren HS, Zhang JC, Jiang JJ, Ding M, Wang YP. Effect of probiotics on the incidence of ventilator-associated pneumonia in critically ill patients: a randomized controlled multicenter trial. Intensive Care Med. 2016 Jun;42(6):1018-28. doi: 10.1007/s00134-016-4303-x. Epub 2016 Apr 4.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 26903336Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M; Sepsis Definitions Task Force. Developing a New Definition and Assessing New Clinical Criteria for Septic Shock: For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):775-87. doi: 10.1001/jama.2016.0289.
- Background: PubMed 22858373Kotzampassi K, Giamarellos-Bourboulis EJ. Probiotics for infectious diseases: more drugs, less dietary supplementation. Int J Antimicrob Agents. 2012 Oct;40(4):288-96. doi: 10.1016/j.ijantimicag.2012.06.006. Epub 2012 Aug 2.
- Background: PubMed 26686273Stavrou G, Giamarellos-Bourboulis EJ, Kotzampassi K. The role of probiotics in the prevention of severe infections following abdominal surgery. Int J Antimicrob Agents. 2015 Dec;46 Suppl 1:S2-4. doi: 10.1016/j.ijantimicag.2015.10.003.
- Background: PubMed 25894405Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.
- Background: PubMed 19820590Giamarellos-Bourboulis EJ, Bengmark S, Kanellakopoulou K, Kotzampassi K. Pro- and synbiotics to control inflammation and infection in patients with multiple injuries. J Trauma. 2009 Oct;67(4):815-21. doi: 10.1097/TA.0b013e31819d979e.
- Individual participant dataSharing planned: No
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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.
Katerina Kotzampassi, MD, PhD study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LactoLevure in people with Ventilator Associated Pneumonia and Infection, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 inclusion and 8 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 31 Aug 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 Greece. 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?
Probiotics for VAP prophylaxis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074552, which also lists 9 linked publications.
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 31 Aug 2021.