Sepsis-3 Study in Northeast Thailand

NCT ID: NCT03379402

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1002 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2023-03-24

Brief Summary

This is an observational study to evaluate the utility of the latest recommendation to define severity of infection for sepsis patients (sepsis-3), and to identify the aetiology and factors associated with outcome of community-acquired sepsis in Northeast Thailand.

Potential study participants will be adult patients who are presented at the hospital with community-acquired sepsis. Clinical specimens (including blood, urine, sputum, throat swabs and pus or wound swab) will be collected from each participant on admission for culture, PCR and serological tests, and other laboratory tests. Participants' treatment will be closely monitored during the duration of their hospital stay. Blood will be again collected at 72 hours after admission. Participants will be contacted at 28 days after admission to determine clinical outcome by phone interview with standardized script.

Conditions

Sepsis; Community-Acquired Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients presenting with sepsis

Adult patients, both males and females, presenting with sepsis will be approached for participation in the study.

Specimens collection

Intervention Type: OTHER

On admission: Blood samples 30.01 mL and other specimens (if available) for culture and other diagnostics tests including sputum, throat swab, urine (midstream urine), and pus which is part of routine practice for patients with sepsis at study site.

Day 3: Blood (15 mL) for culture (10 mL) and PCR (5 mL). There will be no blood collection, if patient is discharged before day 3.

Interventions

Specimens collection

On admission: Blood samples 30.01 mL and other specimens (if available) for culture and other diagnostics tests including sputum, throat swab, urine (midstream urine), and pus which is part of routine practice for patients with sepsis at study site.

Day 3: Blood (15 mL) for culture (10 mL) and PCR (5 mL). There will be no blood collection, if patient is discharged before day 3.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males and females 18 years old.

2. Thai nationality.

3. Required hospitalization as decided by the attending physician

4. Documented by attending physician that an infection is the primary cause of illness leading to the hospitalization. These can be infections due to any pathogens (bacteria, viruses, fungi and parasites).

5. qSOFA (quick Sepsis-related Organ Failure Assessment) score ≥ 2 defined as 2 or more of the following:

• Respiratory rate ≥22 /min or required ventilator
• Alteration of mental status (GCS<15 or 10T with endotracheal tube)
• Systolic blood pressure ≤100 mm Hg

Exclusion Criteria

1. Infection is not suspected to be a primary cause of the current illness episode leading to the hospitalization. For example, community-acquired sepsis is considered to be due to stroke, cardiovascular diseases, acute myocardial infarction, cancer, burn, injury, and trauma.

2. Hospitalized at the study site for this current episode for more than 24 hours before enrollment.

3. Hospitalized for this current episode for more than 72 hours at another primary/referring hospital

4. Prior to this current episode, the patient was admitted to any hospital within the last 30 days.

5. Prior to enrolment, it is documented by the attending physician that hospital acquired infection is associated with the cause of sepsis.

• Confirmed diagnosis by any method of an infection as a major cause of illnesses leading to hospitalization. For example, a patient who already has had a definite diagnosis of malarial infection by blood smear.
• Clinical diagnosis of any specific disease or any specific syndromes such as acute infective diarrhea, acute pneumonia, acute encephalomyelitis and acute myocarditis.
• Suspected of having both infectious and non-infectious diseases and infectious disease is a primary cause of illnesses (primary diagnosis) leading to the hospitalization. For example, acute pneumonia with stroke as an underlying disease, etc.
• Patients who are admitted to other hospitals and referred to the study site. For example a referred patient who admit to the first hospital less than 24 hours prior to enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanpasitthiprasong Hospital

OTHER_GOV

Sponsor Role: collaborator

Mahidol Oxford Tropical Medicine Research Unit

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sappasithiprasong Hospital

Ubon Ratchathani, , Thailand

Countries

Thailand

Other Identifiers

HCR17001

Identifier Type: -

Identifier Source: org_study_id