Epidemiology of Antimicrobial-use and Antimicrobial-resistant Infections in Four Hospitals in Thailand

NCT07082465 | Not Yet Recruiting

• 1 other identifier: Micro2501
• Study Type: observational
• Target: 108,000
• Locations: 1 country
• Sites: 4

Brief Summary

The main goal of this retrospective observational study is to understand how stepping down antibiotic treatment (called antibiotic de-escalation) affects patients who receive it compared to those who don't after received a short-course (≤7 days) of parenteral antibiotics. The investigators will use past medical records from four public referral hospitals in Thailand from the year 2019 to 2024. The investigators will firstly evaluate which types of patients are more likely to receive antibiotic de-escalation. Then, the investigators will estimate the impact of antibiotic de-escalation, while taking those differences into account. This way, it will help us understand the impact of antibiotic de-escalation in real-world clinical practice. The investigators also aim to assess how accurate automated outbreak detection systems are at detecting outbreaks, evaluate patterns of antimicrobial use and antimicrobial-resistant infections, and develop new indicators for antimicrobial stewardship that are applicable for local and national actions in low and middle-income countries.

Conditions

Drug Resistance; Bacterial; Bacteremia

Keywords

Drug Resistance; Bacterial; Bacteremia; Inpatients; Antimicrobial Stewardship; Drug Utilization; Drug Utilization Review; Cluster Analysis; Disease Outbreaks; Epidemiology; Quality Indicators; Health Care

Outcome Measures

Primary Outcomes (2)

• New antimicrobial-resistant bloodstream infection

  Antimicrobial-resistant (AMR) bloodstream infection (BSI) is defined as having blood culture positive for methicillin-resistant S. aureus (MRSA), vancomycin-resistant Enterococcus spp., 3rd-generation cephalosporin-resistant Gram-negative bacterium and carbapenem-resistant Gram-negative bacterium from day 8 to day 30 after starting a parenteral antibiotic therapy.

  6 years

• In-hospital 30-day mortality

  In-hospital mortality is defined as having discharge outcomes recorded as 'death without autopsy', 'death with autopsy' or 'died'. In hospital 30-day mortality will be defined as having in-hospital mortality from day 8 to day 30 after starting a parenteral antibiotic therapy from day 8 to day 30 after starting a parenteral antibiotic therapy.

  6 years

Secondary Outcomes (8)

• Sensitivity of automated outbreak detection systems

  5 years, from 2020 to 2024

• Specificity of automated outbreak detection systems

  5 years, from 2020 to 2024

• Positive predictive value (PPV) of automated outbreak detection systems

  5 years, from 2020 to 2024

• Negative predictive value (NPV) of automated outbreak detection systems

  5 years, from 2020 to 2024

• Day of therapy (DOT) per 1,000 bed-days

  6 years

Study Arms (3)

No antibiotic de-escalation

No antibiotic de-escalation group is defined as patients who are still hospitalized and are receiving a parenteral antibiotic classified as Medium Watch (e.g. Piperacillin-tazobactam), High Watch (e.g. carbapenem) or Reserve (e.g. Tigecycline, Fosfomycin, and Colistin) on day 8 after starting a parenteral antibiotic therapy. Only patients who receive parenteral antibiotics for at least four consecutive days are included as a proxy for presumed severe infection. Day 8 is used as a proxy to represent the day immediately following the end of a short-course (≤7 days) of parenteral antibiotics.

De-escalation by using Access or Low Watch parenteral antibiotics

De-escalation by using Access or Low Watch parenteral antibiotics group is defined as patients who are still hospitalized and are receiving a parenteral antibiotic classified as Access (e.g. ampicillin, gentamicin and amoxicillin-clavulanic acid) or Low Watch (e.g. ceftriaxone) on day 8 after starting a parenteral antibiotic therapy. Only patients who receive parenteral antibiotics for at least four consecutive days are included as a proxy for presumed severe infection. Day 8 is used as a proxy to represent the day immediately following the end of a short-course (≤7 days) of parenteral antibiotics.

De-escalation by cessation of parenteral antibiotics

De-escalation by cessation of parenteral antibiotics group is defined as patients who are still hospitalized and are not receiving any parenteral antibiotics on day 8 after starting a parenteral antibiotic therapy. Only patients who receive parenteral antibiotics for at least four consecutive days are included as a proxy for presumed severe infection. Day 8 is used as a proxy to represent the day immediately following the end of a short-course (≤7 days) of parenteral antibiotics.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024. We expect that the total sample size would be about 10,800,000 inpatients.

You may qualify if:

• All age and gender
• Admitted to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024
• Received a parenteral antibiotic for at least four consecutive days
• Were still hospitalized on day 8 after starting a parenteral antibiotic

You may not qualify if:

• Admitted as day admissions to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024
• Had a clinical specimen collected within 2 calendar days of starting a parenteral antibiotic culture positive for an antimicrobial-resistant organism or Staphylococcus aureus
• Antimicrobial-resistant (AMR) organism is defined as an organism that is resistant to Access and Low Watch antibiotics, and if the organism is the cause of infection, the recommended antimicrobial therapy involves the use of Medium Watch, High Watch or Reserve antibiotics. The common organisms include methicillin-resistant S. aureus, methicillin-resistant coagulase-negative Staphylococcus spp., ampicillin-resistant Enterococcus spp., vancomycin-resistant Enterococcus spp., 3rd-generation cephalosporin-resistant Gram-negative bacterium and carbapenem-resistant Gram-negative bacterium. The definition of organism includes organisms frequently associated with contamination including coagulase-negative staphylococci, viridans group streptococci, Corynebacterium spp., Bacillus spp., Diptheroid spp., Micrococcus spp. and Propionibacterium spp.. All types of specimens are included (e.g. sputum and tracheal suction). We excluded such patients because the study has no clinical data to differentiate whether the isolated AMR organisms are causing infections or represent colonization.
• For secondary objectives
• All age and gender
• Admitted to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024
• Admitted as day admissions to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

Study Sites (4)

Chiangrai Prachanukroh Hospital

Chiang Rai, Chiangrai, Thailand

Location

Phrachomklao Hospital

Phetchaburi, Thailand

Location

Chaoprayayommarat Hospital

Suphan Buri, Thailand

Location

Sunpasitthiprasong Hospital

Ubon Ratchathani, Thailand

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Direk Limmathurotsakul, MD, PhD

  Mahidol Oxford Tropical Medicine Research Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Direk Limmathurotsakul, MD, PhD

CONTACT

+66 85 998 7679; direk@tropmedres.ac

Preeyarach Klaytong

CONTACT

+66 89 896 3419; preeyarach@tropmedres.ac

Study Design

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

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 16, 2026
• Study Completion (Estimated): August 16, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (4)