Mortality Related to AMR in Patients With Hospital-acquired Infection

Hospital-acquired Infections Clinical Trial

— HAMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411538
• Other study ID #: MICRO1707
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: July 2018
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2069
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Exclusion Criteria:

• Clinical symptoms of current infection presented =48 hours of admission

Related Conditions & MeSH terms

• Communicable Diseases
• Cross Infection
• Hospital-acquired Infections
• Infection

Intervention

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

Locations

Country	Name	City	State
Thailand	Sunpasitthiprasong Hospital	Ubon Ratchathani

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Mahidol Oxford Tropical Medicine Research Unit, Sanpasitthiprasong Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality		28 days