An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice - Full Text View

Purpose

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
Nosocomial Infection

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment [ Time Frame: 30 days as from onset of nosocomial infection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number and percentage of patients with nosocomial infections received de-escalation therapy [ Time Frame: 30 days as from onset of nosocomial infection ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The determinants for inappropriate antimicrobial treatment and mortality. [ Time Frame: 30 days as from onset of nosocomial infection ] [ Designated as safety issue: No ]

Estimated Enrollment:	1500
Study Start Date:	November 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Appropriate antimicrobial treatment
2 Inappropriate antimicrobial treatment

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient was diagnosed as nosocomial infection

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864929

Locations

Vietnam
Research Site
Hanoi, Vietnam
Research Site
HCM, Vietnam

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	MC MD, AstraZeneca Vietnam
ClinicalTrials.gov Identifier:	NCT00864929 History of Changes
Other Study ID Numbers:	NIS-IVN-DUM-2008/1
Study First Received:	March 18, 2009
Last Updated:	February 15, 2011
Health Authority:	Vietnam: Ministry of Health

Keywords provided by AstraZeneca:

Non-interventional study
Vietnam
inappropriate treatment
nosocomial infection

Additional relevant MeSH terms:

Cross Infection
Infection
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013