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

Nosocomial Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00864929
• Other study ID #: NIS-IVN-DUM-2008/1
• Status: Completed
• Phase: N/A
• First received: March 18, 2009
• Last updated: February 15, 2011
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Infection
• Nosocomial Infection

Locations

Country	Name	City	State
Vietnam	Research Site	Hanoi
Vietnam	Research Site	HCM

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment		30 days as from onset of nosocomial infection	No
Secondary	The number and percentage of patients with nosocomial infections received de-escalation therapy		30 days as from onset of nosocomial infection	No
Secondary	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	No
Secondary	The determinants for inappropriate antimicrobial treatment and mortality.		30 days as from onset of nosocomial infection	No