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

February 15, 2011 updated by: AstraZeneca
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • HCM, Vietnam
        • Research Site
      • Hanoi, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient was diagnosed as nosocomial infection

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Appropriate antimicrobial treatment
2
Inappropriate antimicrobial treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment
Time Frame: 30 days as from onset of nosocomial infection
30 days as from onset of nosocomial infection

Secondary Outcome Measures

Outcome Measure
Time Frame
The number and percentage of patients with nosocomial infections received de-escalation therapy
Time Frame: 30 days as from onset of nosocomial infection
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
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
30 days as from onset of nosocomial infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 18, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-IVN-DUM-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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