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

NCT ID: NCT00864929

Last Updated: 2011-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Nosocomial Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Appropriate antimicrobial treatment

No interventions assigned to this group

2

Inappropriate antimicrobial treatment

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Vietnam

Principal Investigators

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Phan Anh Tuan Nguyen, MD

Role: STUDY_DIRECTOR

AstraZeneca Vietnam

To Nhu Le, MD

Role: PRINCIPAL_INVESTIGATOR

National Paediatric Insitute

Viet Hoa Le

Role: PRINCIPAL_INVESTIGATOR

The 108 Military Central Hospital

Locations

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Research Site

Hanoi, , Vietnam

Site Status

Research Site

Ho Chi Minh City, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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NIS-IVN-DUM-2008/1

Identifier Type: -

Identifier Source: org_study_id

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