NCT02614144

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
Last Updated

November 25, 2015

Status Verified

November 1, 2015

Enrollment Period

2.8 years

First QC Date

November 20, 2015

Last Update Submit

November 24, 2015

Conditions

Respiratory Tract Infection Bacterial

Keywords

Hospital Acquired PneumoniaMortality

Outcome Measures

Primary Outcomes (1)

  • Mortality scale

    Mortality scale YES/NO

    30 days

Secondary Outcomes (1)

  • Initial empiric antibiotic therapy adequacy scale

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

In intubated patients, secretion samples for microbiology culture tests are obtained by aspiration from the lower airway.

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radovan Uvizl, M.D., Ph.D.

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 25, 2015

Study Start

January 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 25, 2015

Record last verified: 2015-11