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CompletedNCT03379402SEPSISIIIUpdated Jan 13, 2026

Sepsis-3 Study in Northeast Thailand

An observational study in Sepsis and Community-Acquired Infections, sponsored by University of Oxford. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by University of Oxford · Observational

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,002
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Sepsis by University of Oxford — none open to participants now, none under way, none of them phase 3. Sepsis · University of Oxford.

Started
2018
with 1 other
Observational
9 of 13
none open now
Registered
9th of 13
by date

Among the 13 studies in Sepsis by University of Oxford, this one is one of 2 that started in 2018, is one of 9 observational ones, and was the 9th registered.

Sepsis

2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.

Browse Sepsis studies →

Open to participants now

None of the 13 studies in Sepsis by University of Oxford is open now. The open studies under Sepsis, anywhere →

Who these studies take

Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.

This study: 18 Years and older · all sexes.

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This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 13 studies in Sepsis by University of Oxford as a file.
02

Study 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.

03

Conditions studied

  • Sepsis
  • Community-Acquired Infections

Keywords

  • causes of community-acquired sepsis
  • diagnostic tests
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,002 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Adult patients presenting with sepsis

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

    Other: Specimens collection

Interventions

  • OtherSpecimens 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.

06

What researchers measure

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])

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

    Time frame: 2.5 years

  3. Respiration: Type of oxygen support

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

    Time frame: 2.5 years

  4. Respiration: FiO2 (% )

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

    Time frame: 2.5 years

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

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

    Time frame: 2.5 years

  6. Coagulation: Platelet (per μL)

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

    Time frame: 2.5 years

  7. Liver: Total Bilirubin (mg/dL)

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

    Time frame: 2.5 years

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

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

    Time frame: 2.5 years

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

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

    Time frame: 2.5 years

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

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

    Time frame: 2.5 years

  11. Central nervous system: Glasgow Coma Score

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

    Time frame: 2.5 years

  12. Renal: Creatinine (mg/sdL)

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

    Time frame: 2.5 years

  13. Hematology

    Other laboratory measurement

    Time frame: 2.5 years

  14. Blood chemistry

    Other laboratory measurement

    Time frame: 2.5 years

  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

07

Study locations

1 site
  • Sappasithiprasong Hospital
    Ubon Ratchathani, 34000, Thailand
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Mar 2023, 61 months.

Of 492 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's 61 months is above that.

Counting every sponsor, half of 544 studies reached it within 27 months; a quarter within 12 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2017
First posted
Dec 20, 2017
StartActual
Feb 1, 2018
Primary completionActual
Mar 24, 2023
CompletionActual
Mar 24, 2023
Last update
Jan 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03379402
Collaborators
Sanpasitthiprasong Hospital, Mahidol Oxford Tropical Medicine Research Unit
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Feb 1, 2018
Primary completion
Mar 24, 2023
Completion
Mar 24, 2023
Last update
Jan 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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