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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00864929

Enrollment

1500

Registered

2009-03-19

Start date

2009-11-30

Completion date

2010-10-31

Last updated

2011-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nosocomial Infection

Keywords

Non-interventional study, Vietnam, inappropriate treatment, nosocomial infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Vietnam

Outcome results