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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00864929

Collaborator

(none)

1,500

Enrollment

Locations

Duration (Months)

750

Patients Per Site

68.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Nosocomial Infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1 Appropriate antimicrobial treatment
2 Inappropriate antimicrobial treatment

Outcome Measures

Primary Outcome Measures

The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment [30 days as from onset of nosocomial infection]

Secondary Outcome Measures

The number and percentage of patients with nosocomial infections received de-escalation therapy [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 [30 days as from onset of nosocomial infection]
The determinants for inappropriate antimicrobial treatment and mortality. [30 days as from onset of nosocomial infection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.