Mortality Related to AMR in Patients With Hospital-acquired Infection

NCT03411538 | Completed

• 1 other identifier: MICRO1707
• Study Type: observational
• Target: 2,069
• Locations: 1 country
• Sites: 1

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.

Conditions

Hospital-acquired Infections

Keywords

antibiotic-resistant infections; risk factors; prospective surveillance

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  28 days

Study Arms (1)

Hospital-acquired bacterial infection

Other: Collect data on clinical history

Interventions

Collect data on clinical history OTHER

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

Hospital-acquired bacterial infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oxford: lead
• Sanpasitthiprasong Hospital: collaborator
• Mahidol Oxford Tropical Medicine Research Unit: collaborator

Study Sites (1)

Sunpasitthiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Location

Related Publications (1)

• 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.

  PMID: 36092827 DERIVED

Study Officials

• Assoc. Prof. Direk Limmathurotsakul, MD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 26, 2018
• Study Start: March 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: September 16, 2020

Record last verified: 2018-07

Locations

TH (1)