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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00864929
First received: March 18, 2009
Last updated: February 15, 2011
Last verified: February 2011
  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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The determinants for inappropriate antimicrobial treatment and mortality. [ Time Frame: 30 days as from onset of nosocomial infection ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MC MD, AstraZeneca Vietnam
ClinicalTrials.gov Identifier: NCT00864929     History of Changes
Other Study ID Numbers: NIS-IVN-DUM-2008/1
Study First Received: March 18, 2009
Last Updated: February 15, 2011
Health Authority: Vietnam: Ministry of Health

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

Additional relevant MeSH terms:
Cross Infection
Infection
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014