Hospital-acquired Infections Clinical Trial
Official title:
A Prospective Surveillance Study for Outcome and Risk Factors Associated With Antibiotic-resistant Infections Among Patients With Hospital-acquired Infections
This is a prospective surveillance study to estimate excess deaths due to and risk factors associated with antibiotic-resistant infection among patients with hospital-acquired infection (HAI) in a resource-limited setting. We will focus on six pathogenic bacteria that are of clinically important in the hospital.
We will first identify patients with pathogenic bacteria isolated from clinical sample
collected >48 hours after admission. These patients will then be screened for eligibility
criteria. Signed informed consent will be sought from the enrolled patients. The primary
outcome is survival status within 28 days since the first specimen culture positive for one
of the six organisms of interest. All patients with hospital-acquired infection will be
assessed for in-hospital 28-day survival as part of the routine hospital surveillance system.
Follow-up to confirm 28-day outcome via telephone call will be performed only if patient
signed informed consent and permission is granted. All isolates from positive cultures will
be collected and stored securely.
This study will not interfere with standard patient care or routine diagnosis procedure,
hence subject will receive no direct medical harm or benefits from being in the study.
Researchers of this study will not be involved in the management, care and treatment of study
subjects. Patient care will remain under the responsibility of the attending medical staff
according to standard practice of care. The study team will work closely with the hospital
Infectious Control team to screen and enroll patients as part of the HAI surveillance data
system in Sunpasitthiprasong Hospital. This study will be an enhancement of the current HAI
surveillance system, which will provide data on 28-day survival status, Charlson
Comorbidities Index (CCI) score and Sequential Organ Failure Assessment (SOFA) score for each
patient and risk factors related to acquiring hospital-acquired infection to the hospital
Infectious Control (IC) team.
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