Ventilator Associated PneumoniaNCT02928042
Inhibition Effects of Probiotics on Pathogens Associated With VAP
An observational study of Ventilator Associated Pneumonia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates that P. aeruginosa, A. baumannii, K. pneumonia and Staph aureus which are obtained from patients' tracheal aspiration culture who treated with mechanical ventilation will be compared with Lactobacillus (LAB) members and nisin bactriocin in the laboratory. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Lactobacillus bacteria
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2016to Jan 2018
- How long will I take part?
- 7 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who mechanically ventilated at least 48 hours will be included. Patients' tracheal aspirate cultures will be used for study. Pseudomonas aeruginosa, Acinetobacter baumanii, Staphylococcus aureus and Klebsiella pneumoniae will be isolated from tracheal aspiration cultures.Antimicrobial effects of Lactobacillus members will be investigated on the bacteria's growth rate in the laboratory.
Who may be able to join
- Patients who mechanically ventilated at least 48 hours in the intensive care unit
Who cannot join
- Patients who mechanically ventilated less than 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhibition Effects of Probiotics on Pathogens Associated With Ventilator Associated Pneumonia
This study evaluates that P. aeruginosa, A. baumannii, K. pneumonia and Staph aureus which are obtained from patients' tracheal aspiration culture who treated with mechanical ventilation will be compared with Lactobacillus (LAB) members and nisin bactriocin in the laboratory. The aim is to investigate the probiotics' antimicrobial properties and effects on these bacteria's growth rate.
Read the detailed description
Ventilator associated pneumonia (VAP) is one of the most commonly seen hospital-acquired infections that occurs in patients who receive mechanical ventilation. VAP usually occurs 48-72 hours after mechanical ventilation and is related increased incidence of multidrug-resistant infections, increased antibiotic use, extended mechanical ventilation time, increased patient stay in the intensive care unit (ICU), and increased patient stay in the hospital. One recent intervention is the probiotic therapy which is a nonantibiotic strategy for maintenance of the host's aerodigestive microbial balance and VAP prevention.Common causative pathogens of VAP include Gram negative bacteria such as Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter species, and Gram-positive bacteria such as Staphylococcus aureus. In this study, these Gram negative pathogens obtained from mechanical ventilated patients' tracheal aspiration culture and reference bacteria strains will be compared with Lactobacillus (LAB) members and nisin in the laboratory. Probiotics' antimicrobial properties and effects on these bacteria's (obtained from patients and reference strains) growth rate will be investigated.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Lactobacillus bacteria
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus bacteriaOther
Antimicrobial effects of Lactobacillus bacteria (LAB) and nisin bacteriocin on pathogen bacteria and commercial strains of the same bacteria's growth rate will be investigated.
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus bacteria | Pseudomonas aeruginosa, Acinetobacter baumanii, Staph aureus and Klebsiella pneumoniae will be isolated from tracheal aspiration cultures. 80 isolates associated with pneumonia will be identified and made antibiogram with VITEK. Then antimicrobial effects of Lactobacillus bacteria (LAB) (Lc. lactis subsp. lactis (IL 1403), Lc. lactis subsp. lactis (ATCC 11454), Lactobacillus plantarum (FI8595), Leuconostoc mesenterodies subsp. cremoris (DSMZ 20346), Streptococcus thermophilus (NCFB2392), Pediococcus acidophilus (ATCC 25741)) and nisin bacteriocin will be investigated on the bacteria's growth rate in the laboratory. Receives: Other: Lactobacillus bacteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probiotics' antimicrobial properties and effects on P. aeruginosa, A. baumanii, Staph. auresu and K. pneumonia's growth rate.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Cukurova UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Dilek Özcengiz
- Responsible party
- Principal investigator, Feride Karacaer, Cukurova University
- Investigators
- Dilek Özcengiz, Professor, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928042
- Sponsor's protocol ID
- PVAP69
- Status last verified
- Jan 2018
- First submitted
- 6 Oct 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alexandre Y, Le Berre R, Barbier G, Le Blay G. Screening of Lactobacillus spp. for the prevention of Pseudomonas aeruginosa pulmonary infections. BMC Microbiol. 2014 Apr 27;14:107. doi: 10.1186/1471-2180-14-107.
PubMed 24766663Petrof EO, Dhaliwal R, Manzanares W, Johnstone J, Cook D, Heyland DK. Probiotics in the critically ill: a systematic review of the randomized trial evidence. Crit Care Med. 2012 Dec;40(12):3290-302. doi: 10.1097/CCM.0b013e318260cc33.
PubMed 22975886
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhibition Effects of Probiotics on Pathogens Associated With Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT02928042
- Acronym / sponsor ID
- PVAP69
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Dilek Özcengiz
- Study start
- Nov 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 Oct 2016 (estimated)
- 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.
This study evaluates that P. aeruginosa, A. baumannii, K. pneumonia and Staph aureus which are obtained from patients' tracheal aspiration culture who treated with mechanical ventilation will be compared with Lactobacillus (LAB) members and nisin bactriocin in the laboratory. The aim is to investigate the probiotics' antimicrobial properties and effects on these bacteria's growth rate.
Detailed description
Ventilator associated pneumonia (VAP) is one of the most commonly seen hospital-acquired infections that occurs in patients who receive mechanical ventilation. VAP usually occurs 48-72 hours after mechanical ventilation and is related increased incidence of multidrug-resistant infections, increased antibiotic use, extended mechanical ventilation time, increased patient stay in the intensive care unit (ICU), and increased patient stay in the hospital. One recent intervention is the probiotic therapy which is a nonantibiotic strategy for maintenance of the host's aerodigestive microbial balance and VAP prevention.Common causative pathogens of VAP include Gram negative bacteria such as Pseudomonas aeruginosa, Klebsiella pneumoniae, and Acinetobacter species, and Gram-positive bacteria such as Staphylococcus aureus. In this study, these Gram negative pathogens obtained from mechanical ventilated patients' tracheal aspiration culture and reference bacteria strains will be compared with Lactobacillus (LAB) members and nisin in the laboratory. Probiotics' antimicrobial properties and effects on these bacteria's (obtained from patients and reference strains) growth rate will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus bacteria | – | Other: Lactobacillus bacteriaPseudomonas aeruginosa, Acinetobacter baumanii, Staph aureus and Klebsiella pneumoniae will be isolated from tracheal aspiration cultures. 80 isolates associated with pneumonia will be identified and made antibiogram with VITEK. Then antimicrobial effects of Lactobacillus bacteria (LAB) (Lc. lactis subsp. lactis (IL 1403), Lc. lactis subsp. lactis (ATCC 11454), Lactobacillus plantarum (FI8595), Leuconostoc mesenterodies subsp. cremoris (DSMZ 20346), Streptococcus thermophilus (NCFB2392), Pediococcus acidophilus (ATCC 25741)) and nisin bacteriocin will be investigated on the bacteria's growth rate in the laboratory. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who mechanically ventilated at least 48 hours will be included. Patients' tracheal aspirate cultures will be used for study. Pseudomonas aeruginosa, Acinetobacter baumanii, Staphylococcus aureus and Klebsiella pneumoniae will be isolated from tracheal aspiration cultures.Antimicrobial effects of Lactobacillus members will be investigated on the bacteria's growth rate in the laboratory.
Key inclusion criteria (1 listed)
- Patients who mechanically ventilated at least 48 hours in the intensive care unit
Key exclusion criteria (1 listed)
- Patients who mechanically ventilated less than 48 hours
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 |
|---|---|---|
| Lactobacillus bacteriaAntimicrobial effects of Lactobacillus bacteria (LAB) and nisin bacteriocin on pathogen bacteria and commercial strains of the same bacteria's growth rate will be investigated. | Other | Lactobacillus bacteria |
Primary outcome
Probiotics' antimicrobial properties and effects on P. aeruginosa, A. baumanii, Staph. auresu and K. pneumonia's growth rate.
Time frame: 7 months
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 18 Jan 2018.
- Background: PubMed 24766663Alexandre Y, Le Berre R, Barbier G, Le Blay G. Screening of Lactobacillus spp. for the prevention of Pseudomonas aeruginosa pulmonary infections. BMC Microbiol. 2014 Apr 27;14:107. doi: 10.1186/1471-2180-14-107.
- Background: PubMed 22975886Petrof EO, Dhaliwal R, Manzanares W, Johnstone J, Cook D, Heyland DK. Probiotics in the critically ill: a systematic review of the randomized trial evidence. Crit Care Med. 2012 Dec;40(12):3290-302. doi: 10.1097/CCM.0b013e318260cc33.
- 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.
Dilek Özcengiz, Professor principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 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 18 Jan 2018. 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 Turkey (Türkiye). 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?
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' antimicrobial properties and effects on P. aeruginosa, A. baumanii, Staph. auresu and K. pneumonia's growth rate. (time frame: 7 months). 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 NCT02928042, which also lists 2 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 18 Jan 2018.