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SEA050: An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT02157259
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), FHI 360 (Other), Social & Scientific Systems Inc. (Industry)
2,250
Enrollment
15
Locations
26
Duration (Months)
150
Patients Per Site
5.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study of the Causes, Management, and Outcomes of Community-acquired Sepsis and Severe Sepsis in Southeast Asia
    Study Start Date :
    Dec 1, 2013
    Actual Primary Completion Date :
    Feb 1, 2016
    Actual Study Completion Date :
    Feb 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. The etiology of community-acquired sepsis and severe sepsis expressed in percentages of enrolled subjects. [Total length of time that subjects will be in the study is 28 to 35 days.]

    Secondary Outcome Measures

    1. The time from hospital admission to any systemic antibiotic administration. [2 years]

    2. Percentage of initial systemic antimicrobial effective to treat the cause of the infection. [2 years]

    3. Percentage of subjects receiving fluid challenge (giving bolus of fluid) if the patient has hypotension. [2 years]

    4. Percentage of subjects receiving adequate ventilatory support (including percentage of subjects receiving supplemental oxygen, percentage of subjects receiving Positive-end Expiratory Pressure (PEEP). [2 years]

    5. Percentage of subjects receiving low-volume lung-protective ventilation. [2 years]

    6. Percentage of subjects receiving arterial blood gas evaluation). [2 years]

    7. Percentage of subjects receiving renal replacement therapies (including hemodialysis and peritoneal dialysis). [2 years]

    8. Percentage of subjects receiving imaging to determine source or deep foci of infection (including chest radiography, ultrasonogram, CT scan and MRI). [2 years]

    9. Percentage of subjects receiving evaluation by scoring system. [2 years]

    10. Percentage of subjects receiving stress prophylaxis. [2 years]

    11. Percentage of patients receiving deep vein thrombosis (DVT) prophylaxis. [2 years]

    12. Percentage of subjects receiving treatment in ICUs. [2 years]

    13. 28-day mortality rate. [2 years]

    14. Percentage of subjects developing major organ dysfunction; for example ventilatory failure and renal failure. [2 years]

    15. Risk factors associated with sepsis or severe sepsis [2 years]

    16. Prevalence of antimicrobial resistance and its association with appropriate empirical therapy and outcomes. [2 years]

    17. Sensitivities and specificities of selected RDTs in determining the causes of community-acquired sepsis and severe sepsis [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Days and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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%.

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Sardjito Hospital Yogyakarta DI Yogyakarta Indonesia
    2 Cipto Mangunkusumo Hospital Jakarta DKI Jaya Indonesia
    3 Dr. Wahidin Soedirohusodo Makasar Sulawesi Selatan Indonesia
    4 Universitas Hasanuddin Makassar Sulawesi Selatan Indonesia 90245
    5 Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand Bangkok Thailand
    6 Pediatric Unit Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand Bangkok Thailand
    7 Queen Sirikit National Institute of Child Health Bangkok Thailand
    8 Chiangrai Prachanukroh Hospital Chiangrai Thailand
    9 Sappasitthiprasong Hospital Ubon Ratchathani Thailand
    10 National Hospital of Paediatric Hanoi Vietnam
    11 National Hospital of Tropical Diseases Hanoi Vietnam
    12 Children Hospital 1 Ho Chi Minh City Vietnam
    13 Children Hospital 2 Ho Chi Minh City Vietnam
    14 Hospital of Tropical Diseases Ho Chi Minh City Vietnam
    15 Hue Central Hospital Hue City Vietnam

    Sponsors and Collaborators

    • University of Oxford
    • National Institute of Allergy and Infectious Diseases (NIAID)
    • FHI 360
    • Social & Scientific Systems Inc.

    Investigators

    • Principal Investigator: Direk Limmathurotsakul, MD, Mahidol Oxford Tropical Medicine Research Unit

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT02157259
    Other Study ID Numbers:
    • SEA-050 Sepsis Study
    First Posted:
    Jun 5, 2014
    Last Update Posted:
    Feb 18, 2016
    Last Verified:
    Feb 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Feb 18, 2016