Clinical trial NCT00864929: An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice
Official title: An Epidemiological Study on Antimicrobial Treatment of Nosocomial Infections in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Infection
Keywords: Non-interventional study
Vietnam
inappropriate treatment
nosocomial infection
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient was diagnosed as nosocomial infection

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.


Eligibility 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.

Primary outcomes:
measure: The number and percentage of subjects with nosocomial infection received appropriate antimicrobial treatment
timeFrame: 30 days as from onset of nosocomial infection
Secondary outcomes:
measure: The number and percentage of patients with nosocomial infections received de-escalation therapy
timeFrame: 30 days as from onset of nosocomial infection
measure: 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
timeFrame: 30 days as from onset of nosocomial infection
measure: The determinants for inappropriate antimicrobial treatment and mortality.
timeFrame: 30 days as from onset of nosocomial infection
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Research Site
city: HCM
country: Vietnam
facility: Research Site
Study officials:
affiliation: AstraZeneca Vietnam
name: Phan Anh Tuan Nguyen, MD
role: STUDY_DIRECTOR
affiliation: National Paediatric Insitute
name: To Nhu Le, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The 108 Military Central Hospital
name: Viet Hoa Le
role: PRINCIPAL_INVESTIGATOR
References: