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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02928042
Other study ID # PVAP69
Secondary ID
Status Completed
Phase N/A
First received October 6, 2016
Last updated January 17, 2018
Start date November 2016
Est. completion date January 2018

Study information

Verified date January 2018
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. The aim is to investigate the probiotics' antimicrobial properties and effects on these bacteria's growth rate.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients who mechanically ventilated at least 48 hours in the intensive care unit

Exclusion Criteria:

- Patients who mechanically ventilated less than 48 hours

Study Design


Intervention

Other:
Lactobacillus bacteria
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.

Locations

Country Name City State
Turkey Cukurova University Adana

Sponsors (2)

Lead Sponsor Collaborator
Cukurova University Dilek Özcengiz

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Petrof 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Probiotics' antimicrobial properties and effects on P. aeruginosa, A. baumanii, Staph. auresu and K. pneumonia's growth rate. 7 months
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