Clinical trial NCT03039998: Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia
Official title: Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital Acquired Pneumonia
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2017-02-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method.
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Olomouc
name: Tomáš Gabrhelík, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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citation: [Pneumonia-causing bacterial pathogens in intensive care patients]. Klin Mikrobiol Infekc Lek. 2011 Aug;17(4):135-40. Czech.
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. Epub 2008 Nov 7.
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.
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. doi: 10.1097/01.ta.0000088858.22080.cb.
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. doi: 10.1164/ajrccm.157.1.9604070.