An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia
An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia
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.
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
Inclusion Criteria:

 1. Age ≥30 days old and weighing at least 3 kg or more on the day of enrollment into the
 study

 2. Required hospitalization as decided by the attending physician

 3. 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).

 4. Presence of Systemic Inflammatory Response Syndrome (SIRS):

 4.1 For adults (≥ 18 years old), any combination of a minimum of any 3 of the
 following 20 parameters

 -  Fever or hypothermia (Core body temperature defined as >38.3 C or <36.0 C)

 -  Tachycardia (heart rate >90 beats per minute)

 -  Tachypnea (respiratory rate >20 per minute)

 -  Arterial hypotension (systolic blood pressure (SBP) <90 mmHg, mean arterial
 pressure (MAP) <70 mmHg, or SBP decrease >40 mmHg)

 -  White blood cell (WBC) >12,000 u/L or <4000 u/L or immature forms >10%

 -  Platelet count <100,000 u/L

 -  Altered mental status with Glasgow Coma Score (GCS) <15

 -  Hypoxemia (Pulse Oximetry Level <95)

 -  Ileus

 -  Significant edema or positive fluid balance

 -  Decreased capillary refill or mottling

 -  Hyperglycemia (plasma glucose >140 mg/dL) in the absence of diabetes

 -  Plasma C-reactive protein >2 SD above the normal value

 -  Plasma procalcitonin > 2 SD above the normal value

 -  Arterial hypoxemia (PaO2 / FIO2 <300)

 -  Acute oliguria (urine output <0.5 mL/kg/hr or 45 mmol/L for 2 hours)

 -  Creatinine increase >0.5 mg/dL

 -  INR >1.5 or a PTT >60 seconds

 -  Plasma total bilirubin >4 mg/dl or 70 mmol/L

 -  Hyperlactatemia (>1 mmol/L)

 4.2 For pediatric patients (>30 days old and <18 years old), all of the 3 following
 symptoms:

 -  Fever or hypothermia (rectal temperature defined as >38.5 C or <35.0 C [or
 equivalent])

 -  Tachycardia (heart rate >2 SD above the normal value for age). This could be
 absent in hypothermic subject.

 -  Tachypnea (respiratory rate >2 SD above the normal value for age)

 AND at least one of the following parameters:

 -  Altered mental status,(e.g., drowsiness, poor quality of cry, poor reaction to
 parent stimuli, and poor response to social overtures)

 -  Systolic blood pressure <2 SD below the normal value for age OR narrow pulse
 pressure (<20 mmHg) OR poor perfusion (capillary refill >2 sec)

 -  Hypoxemia (Pulse Oximetry Level <95)

 -  White blood cell >15,000 u/L or <5,000 u/L or immature forms >10%.

 5. Informed Consent has been obtained.

 Exclusion Criteria:

 -  Admitted to the study site hospital 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 subject was admitted to any hospital within the
 last 30 days.

 -  An underlying pre-existing condition is thought to have led to or contributed to this
 sepsis episode. For example, sepsis is considered to be directly attributable to
 existing non-infectious conditions such as stroke, cardiovascular diseases, acute
 myocardial infarction, cancer, burn, injury, and trauma.

 -  Prior to enrollment, it is documented by the attending physician that hospital
 acquired infection is associated with the cause of the sepsis or severe sepsis.

 -  The subject has been enrolled into this study or another sepsis study before.