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Trial record 73 of 10491 for:    Anti-Infective Agents AND Bacterial

Epidemiology of Hospital Acquired Pneumonia (HAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02614144
Recruitment Status : Completed
First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Information provided by (Responsible Party):
Radovan Uvizl, University Hospital Olomouc

Brief Summary:
This project aimed at analyzing and assessing of the early and late Hospital-Acquired Pneumonia(HAP) bacterial pathogens and their resistance to antimicrobial agents. The incidence of their resistance to antimicrobial agent is assessed. Included are patients hospitalized in the Intensive Care Departments of cooperated University hospitals, who developed early or late HAP. Bacterial pathogens and their resistance to antibiotics are identified using standard microbiological methods. The patient's mortality with respect to their initial antibiotic therapy is statistically analyzed.

Condition or disease
Respiratory Tract Infection Bacterial

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Identifying Agents of Early-onset and Late-onset Nosocomial Pneumonia in Patients in Intensive Care Through Genetic Analysis of Bacterial DNA and Determination of Their Distribution.
Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mortality scale [ Time Frame: 30 days ]
    Mortality scale YES/NO

Secondary Outcome Measures :
  1. Initial empiric antibiotic therapy adequacy scale [ Time Frame: 1 day ]
    Initial empiric antibiotic adequacy scale YES/NO

Biospecimen Retention:   Samples With DNA
In intubated patients, secretion samples for microbiology culture tests are obtained by aspiration from the lower airway.

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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:   Probability Sample
Study Population
The group comprised patients hospitalized in the Intensive Care Departments of cooperating hospitals between 1 May 2013 and 30 April 2015 who developer signs of HAP.

Inclusion Criteria:

  • The clinical signs of pneumonia are defined as the presence of newly developed or progressive infiltrates on chest radiographs 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 PaO2/FiO2 ≤300 mm Hg.

Exclusion Criteria:

  • Pregnancy.
  • The etiologic agent is considered relevant if cultured in the tracheal secretion at a quantity of >105 CFU/ml.
  • Patients agreement absence.

Additional Information:

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Responsible Party: Radovan Uvizl, Radovan Uvizl, M.D., Ph.D., University Hospital Olomouc Identifier: NCT02614144     History of Changes
Other Study ID Numbers: IGA MZČR NT 14263-3/2013
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: November 25, 2015
Last Verified: November 2015

Keywords provided by Radovan Uvizl, University Hospital Olomouc:
Hospital Acquired Pneumonia

Additional relevant MeSH terms:
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Bacterial Infections
Respiratory Tract Infections
Healthcare-Associated Pneumonia
Lung Diseases
Respiratory Tract Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes