Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02157259
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2014-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia
Status:
COMPLETED
Status Verified Date:
2016-02
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:
SEA050
Brief Summary:
This is an observational study to identify the etiology, management, and outcome of community-acquired sepsis and severe sepsis in children and adults in Southeast Asia. The study will take place in Thailand, Vietnam, and Indonesia, the partner countries of SEAICRN. Potential study patients will be any patients (both children and adults) who are presented at the hospital with community-acquired sepsis or severe sepsis and require hospitalization.
Detailed Description:
The study will enroll 2,250 total patients with sepsis or severe sepsis patients up to 2 years of study. 750 patients will be enrolled in each of Thailand, Vietnam, and Indonesia. There will be 3 sites in each country and some sites will function as cluster/unit sites linking up to 3 hospitals as one 'site' to enable adequate enrollment of both adult and pediatric cases.
Primary objective of the study is to determine the causes of community-acquired sepsis and severe sepsis in adult and pediatric subjects across Southeast Asia.
The secondary objectives are as follow:
* To define the current acute management (within the first 48 hours after admission) of subjects presenting with community-acquired sepsis and severe sepsis and gaps of current practice as defined by the surviving sepsis campaign 2012. This will provide the basis for designing practical interventions to reduce the mortality of subjects with sepsis and severe sepsis in the future.
* To define the clinical outcomes of community-acquired sepsis and severe sepsis in Southeast Asia.
* To identify risk factors associated with sepsis or severe sepsis.
* To determine the extent of antimicrobial resistance in organisms that cause community-acquired sepsis and severe sepsis in Southeast Asia and to determine the association between antimicrobial resistance and mortality.
* To evaluate the accuracy of selected rapid diagnostic tests (RDTs) in determining the causes of community-acquired sepsis and severe sepsis compared to well-defined gold standard tests.
As this is an observational study and not a clinical trial, researchers will not be involved in the management, care and treatment of study subjects. This will remain the responsibility of the attending medical staff according to standard of care (SOC) in the participating hospitals. Therefore the research study will not influence patient management. SOC for sepsis and severe sepsis in each subject will be recorded, and will be reported as summary statistics at the end of the study. This will not be used to influence the management and care of sepsis and severe sepsis cases at the participating hospitals during the study period, but will be used to guide the improvement of the SOC after the study is complete.
NOTE: EACH INSTITUTION IN THIS STUDY IS ITS OWN SPONSOR AS LISTED BELOW:
1. Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
2. Queen Sirikit National Institute of Child Health, Bangkok, Thailand.
3. Children's Hospital 1 Ho Chi Minh City, Vietnam.
4. Children's Hospital 2 Ho Chi Minh City, Vietnam.
5. Hospital for Tropical Diseases Ho Chi Minh City, Vietnam.
6. National Hospital for Pediatrics Hanoi, Vietnam.
7. National Hospital for Tropical Diseases, Hanoi, Vietnam.
8. Hue Central Hospital, Hue City, Vietnam.
9. Dr. Wahidin Soedirohusodo Hospital Makassar, Indonesia.
10. Dr. Sardjito Hospital Yogyakarta, Indonesia.
11. Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
12. Sappasithiprasong Hospital Ubonratchathani, Thailand
13. Chiangrai Prachanukroh Hospital, Chiangrai Thailand
14. University of Oxford, United Kingdom
Primary objective of the study is to determine the causes of community-acquired sepsis and severe sepsis in adult and pediatric subjects across Southeast Asia.
The secondary objectives are as follow:
* To define the current acute management (within the first 48 hours after admission) of subjects presenting with community-acquired sepsis and severe sepsis and gaps of current practice as defined by the surviving sepsis campaign 2012. This will provide the basis for designing practical interventions to reduce the mortality of subjects with sepsis and severe sepsis in the future.
* To define the clinical outcomes of community-acquired sepsis and severe sepsis in Southeast Asia.
* To identify risk factors associated with sepsis or severe sepsis.
* To determine the extent of antimicrobial resistance in organisms that cause community-acquired sepsis and severe sepsis in Southeast Asia and to determine the association between antimicrobial resistance and mortality.
* To evaluate the accuracy of selected rapid diagnostic tests (RDTs) in determining the causes of community-acquired sepsis and severe sepsis compared to well-defined gold standard tests.
As this is an observational study and not a clinical trial, researchers will not be involved in the management, care and treatment of study subjects. This will remain the responsibility of the attending medical staff according to standard of care (SOC) in the participating hospitals. Therefore the research study will not influence patient management. SOC for sepsis and severe sepsis in each subject will be recorded, and will be reported as summary statistics at the end of the study. This will not be used to influence the management and care of sepsis and severe sepsis cases at the participating hospitals during the study period, but will be used to guide the improvement of the SOC after the study is complete.
NOTE: EACH INSTITUTION IN THIS STUDY IS ITS OWN SPONSOR AS LISTED BELOW:
1. Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
2. Queen Sirikit National Institute of Child Health, Bangkok, Thailand.
3. Children's Hospital 1 Ho Chi Minh City, Vietnam.
4. Children's Hospital 2 Ho Chi Minh City, Vietnam.
5. Hospital for Tropical Diseases Ho Chi Minh City, Vietnam.
6. National Hospital for Pediatrics Hanoi, Vietnam.
7. National Hospital for Tropical Diseases, Hanoi, Vietnam.
8. Hue Central Hospital, Hue City, Vietnam.
9. Dr. Wahidin Soedirohusodo Hospital Makassar, Indonesia.
10. Dr. Sardjito Hospital Yogyakarta, Indonesia.
11. Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
12. Sappasithiprasong Hospital Ubonratchathani, Thailand
13. Chiangrai Prachanukroh Hospital, Chiangrai Thailand
14. University of Oxford, United Kingdom
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?: