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SepsisNCT02217592

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

An observational study of Sepsis and Severe Sepsis, run by University of Oxford at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis, Severe Sepsis
How many people
5,020 participants
Where
1 siteThailand
Study dates
20 May 2012to 28 Feb 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Male and female patients, 18 years old with community-acquired sepsis or severe sepsis in Northeast Thailand

Who may be able to join

  • 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)
Show all 25Show fewer
  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Sappasithiprasong Hospital

    Ubon Ratchathani, 34000

Other trials in Thailand

About this study

Official title: Causes and Factors Associated With Outcomes in Community-acquired Sepsis and Severe Sepsis in Northeast (NE) Thailand

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.

Read the 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
Medical subject headings
Sepsis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of enrolled subjects specified by bacterial/viral infection

    Measured: 3 Years

Secondary outcomes (2)

  1. Percentage of deaths caused by community-acquired sepsis and severe sepsis in Northeast Thailand

    Measured: 3 Years

  2. Sensitivities and specificities of diagnostic tests for infection in community-acquired sepsis and severe sepsis in Northeast Thailand

    Measured: 3 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2014 (estimated)
  2. Study start20 May 2012
  3. Primary completion28 Feb 2017
  4. Study completion28 Feb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
5,020 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02217592
Sponsor's protocol ID
MICRO1206
Other IDs
1R01HL113382
Status last verified
Oct 2017
First submitted
1 Aug 2014
Last updated
1 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • Limmathurotsakul D, Wuthiekanun V, Chantratita N, Wongsuvan G, Amornchai P, Day NP, Peacock SJ. Burkholderia pseudomallei is spatially distributed in soil in northeast Thailand. PLoS Negl Trop Dis. 2010 Jun 1;4(6):e694. doi: 10.1371/journal.pntd.0000694.

    PubMed 20532233

  • Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

    PubMed 11445675

  • Cheng AC, West TE, Limmathurotsakul D, Peacock SJ. Strategies to reduce mortality from bacterial sepsis in adults in developing countries. PLoS Med. 2008 Aug 19;5(8):e175. doi: 10.1371/journal.pmed.0050175.

    PubMed 18752342

  • Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM; FEAST Trial Group. Mortality after fluid bolus in African children with severe infection. N Engl J Med. 2011 Jun 30;364(26):2483-95. doi: 10.1056/NEJMoa1101549. Epub 2011 May 26.

    PubMed 21615299

  • Suttinont C, Losuwanaluk K, Niwatayakul K, Hoontrakul S, Intaranongpai W, Silpasakorn S, Suwancharoen D, Panlar P, Saisongkorh W, Rolain JM, Raoult D, Suputtamongkol Y. Causes of acute, undifferentiated, febrile illness in rural Thailand: results of a prospective observational study. Ann Trop Med Parasitol. 2006 Jun;100(4):363-70. doi: 10.1179/136485906X112158.

    PubMed 16762116

  • Gasem MH, Wagenaar JF, Goris MG, Adi MS, Isbandrio BB, Hartskeerl RA, Rolain JM, Raoult D, van Gorp EC. Murine typhus and leptospirosis as causes of acute undifferentiated fever, Indonesia. Emerg Infect Dis. 2009 Jun;15(6):975-7. doi: 10.3201/eid1506.081405.

    PubMed 19523308

  • Phongmany S, Rolain JM, Phetsouvanh R, Blacksell SD, Soukkhaseum V, Rasachack B, Phiasakha K, Soukkhaseum S, Frichithavong K, Chu V, Keolouangkhot V, Martinez-Aussel B, Chang K, Darasavath C, Rattanavong O, Sisouphone S, Mayxay M, Vidamaly S, Parola P, Thammavong C, Heuangvongsy M, Syhavong B, Raoult D, White NJ, Newton PN. Rickettsial infections and fever, Vientiane, Laos. Emerg Infect Dis. 2006 Feb;12(2):256-62. doi: 10.3201/eid1202.050900.

    PubMed 16494751

  • Wijedoru LP, Kumar V, Chanpheaktra N, Chheng K, Smits HL, Pastoor R, Nga TV, Baker S, Wuthiekanun V, Peacock SJ, Putchhat H, Parry CM. Typhoid fever among hospitalized febrile children in Siem Reap, Cambodia. J Trop Pediatr. 2012 Feb;58(1):68-70. doi: 10.1093/tropej/fmr032. Epub 2011 Apr 20.

    PubMed 21508082

  • Suputtamongkol Y, Hall AJ, Dance DA, Chaowagul W, Rajchanuvong A, Smith MD, White NJ. The epidemiology of melioidosis in Ubon Ratchatani, northeast Thailand. Int J Epidemiol. 1994 Oct;23(5):1082-90. doi: 10.1093/ije/23.5.1082.

    PubMed 7860160

  • Limmathurotsakul D, Wongratanacheewin S, Teerawattanasook N, Wongsuvan G, Chaisuksant S, Chetchotisakd P, Chaowagul W, Day NP, Peacock SJ. Increasing incidence of human melioidosis in Northeast Thailand. Am J Trop Med Hyg. 2010 Jun;82(6):1113-7. doi: 10.4269/ajtmh.2010.10-0038.

    PubMed 20519609

  • Fowler VG Jr, Olsen MK, Corey GR, Woods CW, Cabell CH, Reller LB, Cheng AC, Dudley T, Oddone EZ. Clinical identifiers of complicated Staphylococcus aureus bacteremia. Arch Intern Med. 2003 Sep 22;163(17):2066-72. doi: 10.1001/archinte.163.17.2066.

    PubMed 14504120

  • West TE, Chantratita N, Chierakul W, Limmathurotsakul D, Wuthiekanun V, Myers ND, Emond MJ, Wurfel MM, Hawn TR, Peacock SJ, Skerrett SJ. Impaired TLR5 functionality is associated with survival in melioidosis. J Immunol. 2013 Apr 1;190(7):3373-9. doi: 10.4049/jimmunol.1202974. Epub 2013 Feb 27.

    PubMed 23447684

  • Booraphun S, Hantrakun V, Siriboon S, Boonsri C, Poomthong P, Singkaew BO, Wasombat O, Chamnan P, Champunot R, Rudd K, Day NPJ, Dondorp AM, Teparrukkul P, West TE, Limmathurotsakul D. Effectiveness of a sepsis programme in a resource-limited setting: a retrospective analysis of data of a prospective observational study (Ubon-sepsis). BMJ Open. 2021 Feb 18;11(2):e041022. doi: 10.1136/bmjopen-2020-041022.

    PubMed 33602702

  • Wright SW, Lovelace-Macon L, Hantrakun V, Rudd KE, Teparrukkul P, Kosamo S, Liles WC, Limmathurotsakul D, West TE. sTREM-1 predicts mortality in hospitalized patients with infection in a tropical, middle-income country. BMC Med. 2020 Jul 1;18(1):159. doi: 10.1186/s12916-020-01627-5.

    PubMed 32605575

  • Rudd KE, Hantrakun V, Somayaji R, Booraphun S, Boonsri C, Fitzpatrick AL, Day NPJ, Teparrukkul P, Limmathurotsakul D, West TE. Early management of sepsis in medical patients in rural Thailand: a single-center prospective observational study. J Intensive Care. 2019 Dec 2;7:55. doi: 10.1186/s40560-019-0407-z. eCollection 2019.

    PubMed 31827803

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Severe Sepsis, run by University of Oxford at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of enrolled subjects specified by bacterial/viral infection (time frame: 3 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02217592, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.

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