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An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00864929
First Posted: March 19, 2009
Last Update Posted: February 16, 2011
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.
Information provided by:
AstraZeneca
  Purpose
The present study is a retrospective cohort study on patients who suffered a nosocomial infection in major hospitals in Vietnam. Data relating to patient demography include age, gender; medical history; APACHE II score; background conditions, infection details and antimicrobial therapy; and all-caused mortality, time of hospitalization and intensive care. The investigators hypothesis is that antimicrobial treatment inappropriate is highly dependent on incidence of antibiotic resistant pathogens, nonfermentative Gram-negative bacilli and ESBL-producing enterobacteriaceae spp. Variables are demographic characteristics, background conditions, immunosuppressive therapy, antimicrobial susceptibility and inappropriate treatment is explored as possible predictors of mortality.

Condition
Nosocomial Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment [ Time Frame: 30 days as from onset of nosocomial infection ]

Secondary Outcome Measures:
  • The number and percentage of patients with nosocomial infections received de-escalation therapy [ Time Frame: 30 days as from onset of nosocomial infection ]
  • The number and percentage of hospital mortality, the number of days for hospitalization, intensive care among groups of patients who received appropriate or inappropriate antimicrobial treatments [ Time Frame: 30 days as from onset of nosocomial infection ]
  • The determinants for inappropriate antimicrobial treatment and mortality. [ Time Frame: 30 days as from onset of nosocomial infection ]

Estimated Enrollment: 1500
Study Start Date: November 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Appropriate antimicrobial treatment
2
Inappropriate antimicrobial treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient was diagnosed as nosocomial infection
Criteria

Inclusion Criteria:

  • Patient was diagnosed as nosocomial infection defined according to criteria established by the US CDC. The diagnosis criteria for ventilator-associated pneumonia are modified from those established by the American College of Chest Physicians.
  • Patient received empiric antimicrobial therapy within 24 hour from onset of infection and had antimicrobial susceptibility.

Exclusion Criteria:

  • A patient was in part of a controlled clinical trial for the current infection episode.
  • Patients with suspected infections by virus or fungus or tuberculosis will be excluded.
  Contacts and Locations
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): NCT00864929


Locations
Vietnam
Research Site
Hanoi, Vietnam
Research Site
HCM, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Phan Anh Tuan Nguyen, MD AstraZeneca Vietnam
Principal Investigator: To Nhu Le, MD National Paediatric Insitute
Principal Investigator: Viet Hoa Le The 108 Military Central Hospital
  More Information

Responsible Party: MC MD, AstraZeneca Vietnam
ClinicalTrials.gov Identifier: NCT00864929     History of Changes
Other Study ID Numbers: NIS-IVN-DUM-2008/1
First Submitted: March 18, 2009
First Posted: March 19, 2009
Last Update Posted: February 16, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Non-interventional study
Vietnam
inappropriate treatment
nosocomial infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents