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

Hospital Acquired Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039998
• Other study ID #: NT14382
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: January 30, 2017
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The main objective of project will be comparing 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. Obtained results of different methods will enable to determine if the bronchial secretion sample, stomach content sample or oropharyngeal smear are comparable to precise but technically difficult protected brush. 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 will be other priorities of the project. The role of atypical and fungal pathogens in HAP initiation will be discovered as well. 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 will be performed. Finally, percentage of HAP etiological agents resistant to initial empiric antibiotic therapy will be observed.

Project fulfills program objectives of molecular-biologic approaches and research support in infectious diseases domain. It will make contribution to faster and more precise HAP diagnosis and adequate antibiotic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical signs of HAP

• need for intubation and mechanical ventilation

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hospital Acquired Pneumonia
• Pneumonia

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Palacky University

References & Publications (11)

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. Erratum in: Clin Infect Dis. 2010 Nov 1;51(9):1114. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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