Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2026-01-01 @ 11:57 PM
Study NCT ID:
NCT02217592
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2014-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast Thailand
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast (NE) Thailand
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Primary objective: To determine the causes of community-acquired sepsis and severe sepsis in NE Thailand.
Secondary Objectives:
1. To define the clinical outcome of community-acquired sepsis and severe sepsis in NE Thailand.
2. 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.
3. To evaluate diagnostic tests for infection in community-acquired sepsis and severe sepsis in NE Thailand.
NOTE: THIS STUDY IS CO-SPONSORED BY
1. University of Oxford
2. University of Washington
Secondary Objectives:
1. To define the clinical outcome of community-acquired sepsis and severe sepsis in NE Thailand.
2. 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.
3. To evaluate diagnostic tests for infection in community-acquired sepsis and severe sepsis in NE Thailand.
NOTE: THIS STUDY IS CO-SPONSORED BY
1. University of Oxford
2. University of Washington
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01HL113382 | NIH | None | https://reporter.nih.gov/quic… | View |