HAMR: Mortality Related to AMR in Patients With Hospital-acquired Infection

Sponsor

University of Oxford (Other)

Overall Status

Completed

CT.gov ID

NCT03411538

Collaborator

Sanpasitthiprasong Hospital (Other), Mahidol Oxford Tropical Medicine Research Unit (Other)

2,069

Enrollment

Location

Actual Duration (Months)

86.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hospital-acquired Infections	Other: Collect data on clinical history

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

2069 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Prospective Surveillance Study for Outcome and Risk Factors Associated With Antibiotic-resistant Infections Among Patients With Hospital-acquired Infections

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Feb 28, 2020

Actual Study Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Hospital-acquired bacterial infection	Other: Collect data on clinical history Collect data on clinical history, clinical manifestation, comorbidity, admission data, use of invasive medical intervention, history of antibiotic treatment and antibiotic susceptibility test results

Arm

Intervention/Treatment

Hospital-acquired bacterial infection

Other: Collect data on clinical history

Collect data on clinical history, clinical manifestation, comorbidity, admission data, use of invasive medical intervention, history of antibiotic treatment and antibiotic susceptibility test results

Outcome Measures

Primary Outcome Measures

28-day mortality [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female of any age admit at Sunpasitthiprasong Hospital
At least one of the six organisms, which include Staphylococcus aureus, Enterococcus spp., Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter spp., isolated from clinical specimen >48 hours after admission
Acquired Bloodstream infection (BSI), Lower-respiratory tract infection(LRTI), Skin/Soft tissue infection (SSTI), Surgical-site infection (SSI), Urinary tract infection (UTI) or infection at other body sites >48 hours after admit at the hospital