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SepsisSEA050NCT02157259

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

An observational study of Sepsis and Severe Sepsis, run by University of Oxford at 15 sites in 3 countries.

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 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. Read more about this study

Who is it for?
Ages 30 days and older
Conditions the study is for
Sepsis, Severe Sepsis
How many people
2,250 participants
Where
15 sitesin 3 countries
Study dates
Dec 2013to Feb 2016
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 30 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • Age ≥30 days old and weighing at least 3 kg or more on the day of enrollment into the study
  • 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 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)
Show all 35Show 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 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%.
  • Informed Consent has been obtained.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Vietnam6 sites

  • National Hospital of Paediatric

    Hanoi, Hanoi

  • National Hospital of Tropical Diseases

    Hanoi, Hanoi

  • Children Hospital 1

    Ho Chi Minh City, Ho Chi Minh City

  • Children Hospital 2

    Ho Chi Minh City, Ho Chi Minh City

  • Hospital of Tropical Diseases

    Ho Chi Minh City, Ho Chi Minh City

  • Hue Central Hospital

    Huế, Hue City

Other trials in Vietnam

Thailand5 sites

  • Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

    Bangkok, Bangkok

  • Pediatric Unit Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

    Bangkok, Bangkok

  • Queen Sirikit National Institute of Child Health

    Bangkok, Bangkok

  • Chiangrai Prachanukroh Hospital

    Chiangrai, Chiangrai

  • Sappasitthiprasong Hospital

    Ubon Ratchathani, Changwat Ubon Ratchathani

Other trials in Thailand

Indonesia4 sites

  • Cipto Mangunkusumo Hospital

    Jakarta, DKI Jaya

  • Universitas Hasanuddin

    Makassar, South Sulawesi, 90245

  • Dr. Wahidin Soedirohusodo

    Makassar, South Sulawesi

  • Dr. Sardjito Hospital

    Yogyakarta, DI Yogyakarta

Other trials in Indonesia

About this study

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.

Read the 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
Medical subject headings
Sepsis

What is being measured

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

  1. The etiology of community-acquired sepsis and severe sepsis expressed in percentages of enrolled subjects.

    Measured: Total length of time that subjects will be in the study is 28 to 35 days.

Secondary outcomes (17)

  1. The time from hospital admission to any systemic antibiotic administration.

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 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).

    Measured: 2 years

  5. Percentage of subjects receiving low-volume lung-protective ventilation.

    Measured: 2 years

  6. Percentage of subjects receiving arterial blood gas evaluation).

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

  9. Percentage of subjects receiving evaluation by scoring system.

    Measured: 2 years

  10. Percentage of subjects receiving stress prophylaxis.

    Measured: 2 years

  11. Percentage of patients receiving deep vein thrombosis (DVT) prophylaxis.

    Measured: 2 years

  12. Percentage of subjects receiving treatment in ICUs.

    Measured: 2 years

  13. 28-day mortality rate.

    Measured: 2 years

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

    Measured: 2 years

  15. Risk factors associated with sepsis or severe sepsis

    Measured: 2 years

  16. Prevalence of antimicrobial resistance and its association with appropriate empirical therapy and outcomes.

    Measured: 2 years

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

    Measured: 2 years

Timeline

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

  1. First posted5 Jun 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

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
2,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02157259
Sponsor's protocol ID
SEA-050 Sepsis Study
Acronym
SEA050
Status last verified
Feb 2016
First submitted
20 May 2014
Last updated
18 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • World Health Organization (2008) The global burden of disease: 2004 update.

  • Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41.

    PubMed 18158437

  • 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

  • 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

  • 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

  • Hoa NT, Diep TS, Wain J, Parry CM, Hien TT, Smith MD, Walsh AL, White NJ. Community-acquired septicaemia in southern Viet Nam: the importance of multidrug-resistant Salmonella typhi. Trans R Soc Trop Med Hyg. 1998 Sep-Oct;92(5):503-8. doi: 10.1016/s0035-9203(98)90891-4.

    PubMed 9861362

  • 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

  • Bhengsri S, Baggett HC, Jorakate P, Kaewpan A, Prapasiri P, Naorat S, Thamthitiwat S, Tanwisaid K, Chantra S, Salika P, Dejsirilert S, Peruski LF, Maloney SA. Incidence of bacteremic melioidosis in eastern and northeastern Thailand. Am J Trop Med Hyg. 2011 Jul;85(1):117-20. doi: 10.4269/ajtmh.2011.11-0070.

    PubMed 21734135

  • Hashairi F, Hasan H, Azlan K, Deris ZZ. An eight-year review of blood culture and susceptibility among sepsis cases in an emergency department in Northeastern Malaysia. Trop Biomed. 2011 Dec;28(3):599-605.

    PubMed 22433889

  • Deen J, von Seidlein L, Andersen F, Elle N, White NJ, Lubell Y. Community-acquired bacterial bloodstream infections in developing countries in south and southeast Asia: a systematic review. Lancet Infect Dis. 2012 Jun;12(6):480-7. doi: 10.1016/S1473-3099(12)70028-2.

    PubMed 22632186

  • Angkasekwinai N, Rattanaumpawan P, Thamlikitkul V. Epidemiology of sepsis in Siriraj Hospital 2007. J Med Assoc Thai. 2009 Mar;92 Suppl 2:S68-78.

    PubMed 19562989

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Severe Sepsis, run by University of Oxford at 15 sites in 3 countries.

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 35 inclusion and 6 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 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Vietnam, Thailand, Indonesia. 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?

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.). 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 NCT02157259, which also lists 26 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 18 Feb 2016.

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