Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia

NCT03039998 | Completed

• 1 other identifier: NT14382
• Study Type: observational
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of project is to compare validity of sampling methods performed routinely (bronchial secretion, stomach content, oropharyngeal smear) for determination of etiological agent responsible for hospital-acquired pneumonia (HAP) in critically ill patients to bronchoscopy-assisted protected brush method. Evaluation of the present clinical praxis using bronchial secretion sampling in HAP diagnostics and detection of the most common etiological agents in patients with HAP are other priorities of the project. Aiming to confirm or exclude the diagnosis of HAP, determine the sources and possible routes of bacterial pathogens transmission molecular biology analysis of etiological agents is performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.

Conditions

Hospital Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.

  Obtaining 4 types of agent samples: endotracheal aspirate, gastric aspirate, oropharyngeal swab and protected specimen brushing when clinical signs of HAP arisen and after 72 hours

  72 hours

Study Arms (1)

HAP Patients

HAP, intubated and mechanically ventilated.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients hospitalized in the Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc fulfilling HAP criteria will be enrolled in the study: presence of newly developed or progressive infiltrates on chest radiographs after minimum of 48hours of hospitalization plus at least two other signs of respiratory tract infection: temperature \>38 °C, purulent sputum, leukocytosis \>10x103/mm3 or leukopenia \<4x103/mm3, signs of inflammation on auscultation, cough and/or respiratory insufficiency with oxygenation index (Horowitz) PaO2/ FiO2 ≤300 mm Hg. Clinically ongoing lung inflammation is verified by chest radiograph or CT in the mechanically ventilated patient.

You may qualify if:

• clinical signs of HAP
• need for intubation and mechanical ventilation

You may not qualify if:

• inability to obtain samples in 24 hours after clinical diagnosis of HAP

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Palacky University: collaborator

Related Publications (11)

• Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.

  PMID: 7637145 BACKGROUND

• Uvizl R, Hanulik V, Husickova V, Sedlakova MH, Adamus M, Kolar M. Hospital-acquired pneumonia in ICU patients. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2011 Dec;155(4):373-8. doi: 10.5507/bp.2011.067.

  PMID: 22336651 BACKGROUND

• American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.

  PMID: 15699079 BACKGROUND

• Craven DE, Palladino R, McQuillen DP. Healthcare-associated pneumonia in adults: management principles to improve outcomes. Infect Dis Clin North Am. 2004 Dec;18(4):939-62. doi: 10.1016/j.idc.2004.08.001.

  PMID: 15555833 BACKGROUND

• Uvizl R, Adamus M, Cerny V, Dusek L, Jarkovsky J, Sramek V, Matejovic M, Stourac P, Kula R, Malaska J, Sevcik P. Patient survival, predictive factors and disease course of severe sepsis in Czech intensive care units: A multicentre, retrospective, observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2016 Jun;160(2):287-97. doi: 10.5507/bp.2015.052. Epub 2015 Oct 23.

  PMID: 26526190 BACKGROUND

• Jones RN. Microbial etiologies of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S81-7. doi: 10.1086/653053.

  PMID: 20597676 BACKGROUND

• [Pneumonia-causing bacterial pathogens in intensive care patients]. Klin Mikrobiol Infekc Lek. 2011 Aug;17(4):135-40. Czech.

  PMID: 22052100 BACKGROUND

• Torres A, Ewig S, Lode H, Carlet J; European HAP working group. Defining, treating and preventing hospital acquired pneumonia: European perspective. Intensive Care Med. 2009 Jan;35(1):9-29. doi: 10.1007/s00134-008-1336-9. Epub 2008 Nov 7.

  PMID: 18989656 BACKGROUND

• Kowalczyk W, Rybicki Z, Tomaszewski D, Truszczynski A, Guzek A. [The comparison of different bronchial aspirate culturing methods in patients with ventilator-associated pneumonia (VAP)]. Anestezjol Intens Ter. 2011 Apr-Jun;43(2):74-9. Polish.

  PMID: 22011866 BACKGROUND

• Butler KL, Best IM, Oster RA, Katon-Benitez I, Lynn Weaver W, Bumpers HL. Is bilateral protected specimen brush sampling necessary for the accurate diagnosis of ventilator-associated pneumonia? J Trauma. 2004 Aug;57(2):316-22. doi: 10.1097/01.ta.0000088858.22080.cb.

  PMID: 15345979 BACKGROUND

• Gerbeaux P, Ledoray V, Boussuges A, Molenat F, Jean P, Sainty JM. Diagnosis of nosocomial pneumonia in mechanically ventilated patients: repeatability of the bronchoalveolar lavage. Am J Respir Crit Care Med. 1998 Jan;157(1):76-80. doi: 10.1164/ajrccm.157.1.9604070.

  PMID: 9445281 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

endotracheal aspirate, gastric aspirate, oropharyngeal swab, protected specimen brushing

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomáš Gabrhelík, MD, PhD

  University Hospital Olomouc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radovan Uvízl, MD, PhD

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: February 1, 2017
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 1, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share