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

February 17, 2016 updated by: University of Oxford
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DI Yogyakarta
      • Yogyakarta, DI Yogyakarta, Indonesia
        • Dr. Sardjito Hospital
    • DKI Jaya
      • Jakarta, DKI Jaya, Indonesia
        • Cipto Mangunkusumo hospital
    • Sulawesi Selatan
      • Makasar, Sulawesi Selatan, Indonesia
        • Dr. Wahidin Soedirohusodo
      • Makassar, Sulawesi Selatan, Indonesia, 90245
        • Universitas Hasanuddin
  • Thailand
      • Bangkok, Thailand
        • Queen Sirikit National Institute of Child Health
      • Bangkok, Thailand
        • Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
      • Bangkok, Thailand
        • Pediatric Unit Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
      • Chiangrai, Thailand
        • Chiangrai Prachanukroh Hospital
      • Ubon Ratchathani, Thailand
        • Sappasitthiprasong Hospital
  • Vietnam
      • Hanoi, Vietnam
        • National Hospital of Paediatric
      • Hanoi, Vietnam
        • National Hospital of Tropical Diseases
      • Ho Chi Minh City, Vietnam
        • Children Hospital 1
      • Ho Chi Minh City, Vietnam
        • Children Hospital 2
      • Ho Chi Minh City, Vietnam
        • Hospital of Tropical Diseases
      • Hue City, Vietnam
        • Hue Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Male and female patients, age 30 days on the day of enrollment with community-acquired sepsis or severe sepsis in Southeast Asia. Of the 2,250 enrolled patients, 1,125 will be adults and 1,125 will be children.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The etiology of community-acquired sepsis and severe sepsis expressed in percentages of enrolled subjects.
Time Frame: Total length of time that subjects will be in the study is 28 to 35 days.
Total length of time that subjects will be in the study is 28 to 35 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
The time from hospital admission to any systemic antibiotic administration.
Time Frame: 2 years
2 years
Percentage of initial systemic antimicrobial effective to treat the cause of the infection.
Time Frame: 2 years
2 years
Percentage of subjects receiving fluid challenge (giving bolus of fluid) if the patient has hypotension.
Time Frame: 2 years
2 years
Percentage of subjects receiving adequate ventilatory support (including percentage of subjects receiving supplemental oxygen, percentage of subjects receiving Positive-end Expiratory Pressure (PEEP).
Time Frame: 2 years
2 years
Percentage of subjects receiving low-volume lung-protective ventilation.
Time Frame: 2 years
2 years
Percentage of subjects receiving arterial blood gas evaluation).
Time Frame: 2 years
2 years
Percentage of subjects receiving renal replacement therapies (including hemodialysis and peritoneal dialysis).
Time Frame: 2 years
2 years
Percentage of subjects receiving imaging to determine source or deep foci of infection (including chest radiography, ultrasonogram, CT scan and MRI).
Time Frame: 2 years
2 years
Percentage of subjects receiving evaluation by scoring system.
Time Frame: 2 years
2 years
Percentage of subjects receiving stress prophylaxis.
Time Frame: 2 years
2 years
Percentage of patients receiving deep vein thrombosis (DVT) prophylaxis.
Time Frame: 2 years
2 years
Percentage of subjects receiving treatment in ICUs.
Time Frame: 2 years
2 years
28-day mortality rate.
Time Frame: 2 years
2 years
Percentage of subjects developing major organ dysfunction; for example ventilatory failure and renal failure.
Time Frame: 2 years
2 years
Risk factors associated with sepsis or severe sepsis
Time Frame: 2 years
2 years
Prevalence of antimicrobial resistance and its association with appropriate empirical therapy and outcomes.
Time Frame: 2 years
2 years
Sensitivities and specificities of selected RDTs in determining the causes of community-acquired sepsis and severe sepsis
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

June 3, 2014

First Posted (ESTIMATE)

June 5, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEA-050 Sepsis Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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