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

Completed

• Conditions: Nosocomial Infection

• Registration Number: NCT00864929
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-18
• Study First Submitted QC: 2009-03-18
• Study First Posted: 2009-03-19
• Study Start: 2009-11
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-15
• Last Update Posted: 2011-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment	30 days as from onset of nosocomial infection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇻🇳 HCM, Vietnam