Clinical trial NCT03411538: Mortality Related to AMR in Patients With Hospital-acquired Infection
Official title: A Prospective Surveillance Study for Outcome and Risk Factors Associated With Antibiotic-resistant Infections Among Patients With Hospital-acquired Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital-acquired Infections
Keywords: antibiotic-resistant infections
risk factors
prospective surveillance
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Sanpasitthiprasong Hospital
name: Mahidol Oxford Tropical Medicine Research Unit
First posted: 2018-01-26
Enrollment: 2069
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target study subjects include male and female patients of any age admit at the hospital, and acquired hospital-acquired bacterial infection during hospital stay. We will focus on six key pathogens that were in the WHO global priority list of antibiotic-resistant bacteria and are also of clinical importance in resource-limited settings, namely:

* Staphylococcus aureus
* Enterococcus spp
* Escherichia coli
* Klebsiella pneumoniae
* Pseudomonas aeruginosa
* Acinetobacter spp

The severity of underlying illness will be assessed using Charlson Comorbidity Index (CCI) score and severity of the infection will be assessed using Sequential Organ Failure Assessment (SOFA) score. These score will be reported to the physician whenever appropriate.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ubon Ratchathani
country: Thailand
facility: Sunpasitthiprasong Hospital
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Assoc. Prof. Direk Limmathurotsakul, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim C, Teparrukkul P, Nuntalohit S, Boonsong S, Nilsakul J, Srisamang P, Sartorius B, White NJ, Day NPJ, Cooper BS, Limmathurotsakul D. Excess Mortality Attributable to Hospital-Acquired Antimicrobial-Resistant Infections: A 2-Year Prospective Surveillance Study in Northeast Thailand. Open Forum Infect Dis. 2022 Jun 20;9(9):ofac305. doi: 10.1093/ofid/ofac305. eCollection 2022 Sep.