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Completed

NCT Number: NCT03379402

Sepsis-3 Study in Northeast Thailand

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sappasithiprasong Hospital

Ubon Ratchathani, 34000, Thailand

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 18 years old.
  • Thai nationality.
  • Required hospitalization as decided by the attending physician
  • 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).
  • 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

  • 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.
  • Hospitalized at the study site for this current episode for more than 24 hours before enrollment.
  • Hospitalized for this current episode for more than 72 hours at another primary/referring hospital
  • Prior to this current episode, the patient was admitted to any hospital within the last 30 days.
  • Prior to enrolment, it is documented by the attending physician that hospital acquired infection is associated with the cause of sepsis.

Please note that the following conditions are not exclusion criteria, and patients with the following conditions can be enrolled into the study.

  • 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.

Treatment and study plan

Specimens collection

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.

Primary outcomes

  1. 28-day mortality after admission date

    Time frame: 2.5 years

Secondary outcomes

  1. Causative organisms of community-acquired sepsis

    Time frame: 2.5 years

  2. Respiration: Blood gas (PaO2 [mmHg])

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  3. Respiration: Type of oxygen support

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  4. Respiration: FiO2 (% )

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  5. Respiration: SpO2 by pulse oximeter level (%)

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  6. Coagulation: Platelet (per μL)

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  7. Liver: Total Bilirubin (mg/dL)

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  8. Cardiovascular: Mean Arterial Pressure (MAP) at enrolment (mmHg)

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  9. Cardiovascular: Dosages (μg/kg/min) of inotropic

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  10. Cardiovascular: Dosages (μg/kg/min) of vasopressor agents

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  11. Central nervous system: Glasgow Coma Score

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  12. Renal: Creatinine (mg/sdL)

    Time frame: 2.5 years

    Clinical parameters evaluated as according to Sepsis-3 guideline; Sequential Organ Failure Assessment (SOFA)

  13. Hematology

    Time frame: 2.5 years

    Other laboratory measurement

  14. Blood chemistry

    Time frame: 2.5 years

    Other laboratory measurement

  15. Causes of sepsis associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand

    Time frame: 2.5 years

  16. Sepsis resuscitation associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand

    Time frame: 2.5 years

  17. Antimicrobial treatment associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand

    Time frame: 2.5 years

  18. Inflammatory associated with mortality outcome in patients with community-acquired sepsis in northeast Thailand

    Time frame: 2.5 years

  19. Genetics factors with mortality outcome in patients with community-acquired sepsis in northeast Thailand

    Time frame: 2.5 years

  20. Diagnostic tests for infection in community-acquired sepsis in NE Thailand

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit
  • Sanpasitthiprasong Hospital

Registry information

Official study title

Utility of Sepsis-3 Definition, Causes and Factors Associated With Outcomes in Community-acquired Sepsis in Ubon Ratchathani, Northeast Thailand

Acronym: SEPSISIII

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2017
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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