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Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast Thailand

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02217592
Recruitment Status : Completed
First Posted : August 15, 2014
Last Update Posted : November 1, 2017
Sponsor:
Collaborators:
Wellcome Trust
National Institutes of Health (NIH)
University of Washington
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date August 1, 2014
First Posted Date August 15, 2014
Last Update Posted Date November 1, 2017
Actual Study Start Date May 20, 2012
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2014)
Percentage of enrolled subjects specified by bacterial/viral infection [ Time Frame: 3 Years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02217592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 13, 2014)
  • Percentage of deaths caused by community-acquired sepsis and severe sepsis in Northeast Thailand [ Time Frame: 3 Years ]
  • Sensitivities and specificities of diagnostic tests for infection in community-acquired sepsis and severe sepsis in Northeast Thailand [ Time Frame: 3 Years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast Thailand
Official Title Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast (NE) Thailand
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.

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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood. Urine, pus, sputum, throat swab, and stool (if available)
Sampling Method Probability Sample
Study Population Male and female patients, 18 years old with community-acquired sepsis or severe sepsis in Northeast Thailand
Condition
  • Sepsis
  • Severe Sepsis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 13, 2014)
5020
Original Estimated Enrollment Same as current
Actual Study Completion Date February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males and females 18 years old
  • Thai nationality
  • Required hospitalization as decided by the attending physician
  • 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)
  • Presence of any 3 of the following Systemic Inflammatory Response Syndrome (SIRS)

    • 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/µL < 4000/µL or immature forms > 10%
    • Platelet count < 100,000/microlitre
    • 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 aPTT > 60 seconds
    • Plasma total bilirubin > 4 mg/dl or 70 mmol/L
    • Hyperlactatemia (> 1 mmol/L)

Exclusion Criteria

  • Infection is not suspected to be a primary cause of the current illness episode leading to the hospitalization. For example, community-acquired sepsis or severe sepsis is considered to be due to stroke, cardiovascular diseases, acute myocardial infarction, cancer, burn, injury, and trauma
  • Hospitalized at this study site 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 patient was admitted to any hospital within the last 30 days
  • Prior to enrolment, it is documented by the attending physician that hospital acquired infection is associated with the cause of sepsis or severe sepsis

Please note that the following conditions are not exclusion criteria, and patients with the following conditions can be enrolled into the study

  • Confirmed diagnosis by any method of an infection as a major cause of illnesses leading to hospitalization. For example, a patient who already has had a definite diagnosis of malarial infection by blood smear
  • Clinical diagnosis of any specific disease or any specific syndromes such as acute infective diarrhea, acute pneumonia, acute encephalomyelitis and acute myocarditis
  • Suspected of having both infectious and non-infectious diseases and infectious disease is a primary cause of illnesses (primary diagnosis) leading to the hospitalization. For example, acute pneumonia with stroke as an underlying disease, etc
  • Patients who are admitted to other hospitals and referred to the study site. For example a referred patient who admit to the first hospital less than 48 hours prior to enrollment
  • Patients fulfilling the inclusion criteria without having result of complete blood count or result of all parameters in the inclusion criteria. For example, a patient who has hypothermia, tachycardia and tachypnea completes the criteria of SIRS even without the result of complete blood count or the result of other parameters such as INR, or plasma procalcitonin
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT02217592
Other Study ID Numbers MICRO1206
1R01HL113382 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators
  • Wellcome Trust
  • National Institutes of Health (NIH)
  • University of Washington
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Dr.Direk Limmathurotsakul Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol university, Thailand
PRS Account University of Oxford
Verification Date October 2017