Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast Thailand
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|ClinicalTrials.gov Identifier: NCT02217592|
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : November 1, 2017
This is an observational study to identify the aetiology and factors associated with outcome of community-acquired sepsis and severe 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 and throat swabs) will be collected from each participant on admission for culture, PCR and serological tests, and other laboratory tests, including inflammatory markers and genotyping. 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.
There will be a total of 5,020 patients enrolled in this study over 3 years.
|Condition or disease|
|Sepsis Severe Sepsis|
Primary objective: To determine the causes of community-acquired sepsis and severe sepsis in NE Thailand.
- To define the clinical outcome of community-acquired sepsis and severe sepsis in NE Thailand.
- To determine factors associated with inflammatory response, organ failure, and mortality in community-acquired sepsis and severe sepsis in NE Thailand, including causes of sepsis, sepsis resuscitation, antimicrobial treatment and genetic factors.
- To evaluate diagnostic tests for infection in community-acquired sepsis and severe sepsis in NE Thailand.
NOTE: THIS STUDY IS CO-SPONSORED BY
- University of Oxford
- University of Washington
|Study Type :||Observational|
|Actual Enrollment :||5020 participants|
|Official Title:||Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast (NE) Thailand|
|Actual Study Start Date :||May 20, 2012|
|Actual Primary Completion Date :||February 28, 2017|
|Actual Study Completion Date :||February 28, 2017|
- Percentage of enrolled subjects specified by bacterial/viral infection [ Time Frame: 3 Years ]
- Percentage of deaths caused by community-acquired sepsis and severe sepsis in Northeast Thailand [ Time Frame: 3 Years ]
- Sensitivities and specificities of diagnostic tests for infection in community-acquired sepsis and severe sepsis in Northeast Thailand [ Time Frame: 3 Years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217592
|Ubon Ratchathani, Thailand, 34000|
|Principal Investigator:||Dr.Direk Limmathurotsakul||Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand|