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OpenTrials
Completed

NCT Number: NCT00864929

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Hanoi, Vietnam

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment

    Time frame: 30 days as from onset of nosocomial infection

Secondary outcomes

  1. The number and percentage of patients with nosocomial infections received de-escalation therapy

    Time frame: 30 days as from onset of nosocomial infection

  2. 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

  3. The determinants for inappropriate antimicrobial treatment and mortality.

    Time frame: 30 days as from onset of nosocomial infection

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 19, 2009
Registry last updated
Feb 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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