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

NCT00864929 | Completed

• 1 other identifier: NIS-IVN-DUM-2008/1
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 2

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.

Conditions

Nosocomial Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  30 days as from onset of nosocomial infection

Secondary Outcomes (3)

• 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

Study Arms (2)

1

Appropriate antimicrobial treatment

2

Inappropriate antimicrobial treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient was diagnosed as nosocomial infection

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Hanoi, Vietnam

Location

Research Site

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Phan Anh Tuan Nguyen, MD

  AstraZeneca Vietnam

  STUDY DIRECTOR

• To Nhu Le, MD

  National Paediatric Insitute

  PRINCIPAL INVESTIGATOR

• Viet Hoa Le

  The 108 Military Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 16, 2011

Record last verified: 2011-02

Locations

VN (2)