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

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ClinicalTrials.gov Identifier: NCT03039998
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Palacky University
Information provided by (Responsible Party):
Radovan Uvizl, University Hospital Olomouc

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.

Condition or disease
Hospital Acquired Pneumonia

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.

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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validity of Biological Material Sampling in Patients With Hospital-acquired Pneumonia
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015


Group/Cohort
HAP Patients
HAP, intubated and mechanically ventilated.



Primary Outcome Measures :
  1. Sensitivity and specificity of diagnostic methods etiological agents HAP. Scale: sensitivity and specificity of each method. [ Time Frame: 72 hours ]
    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


Biospecimen Retention:   Samples Without DNA
endotracheal aspirate, gastric aspirate, oropharyngeal swab, protected specimen brushing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039998


Sponsors and Collaborators
University Hospital Olomouc
Palacky University
Investigators
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Principal Investigator: Tomáš Gabrhelík, MD, PhD University Hospital Olomouc
Publications:

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Responsible Party: Radovan Uvizl, Radovan Uvízl, MD, PhD, University Hospital Olomouc
ClinicalTrials.gov Identifier: NCT03039998    
Other Study ID Numbers: NT14382
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pneumonia
Healthcare-Associated Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes