InfectionSORTNCT07397689
Early Sepsis Recognition Tool
An observational study of Infection and Sepsis, run by KK Women's and Children's Hospital at 19 sites in 9 countries.
Trial summary
This study seeks to develop early recognition tools specially designed for children meeting the Phoenix definition and explore implementation science aspects by investigating facilitators and barriers to adopting Phoenix sepsis criteria in clinical practice. Read more about this study
- Who is it for?
- Ages Up to 18 years
- What is being tested?
- Application of the Phoenix Sepsis Score
- How many people
- 40,000 participants
- Where
- 19 sitesin 9 countries
- Study dates
- 1 Feb 2026to Dec 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children < 18 years old with suspected infection. Suspected infection is defined as children who undergo blood cultures and receive broad-spectrum anti-microbial agents in the first 24 hours of admission. Anti-microbial agents include antibiotics, antiviral, antifungal and antimalarial medications.
Who may be able to join
- Children < 18 years old
- Suspected infection defined by (1) blood culture performed (irrespective of result), AND (2) use of broad-spectrum anti-microbial agents, in the first 24 hours of admission
Who cannot join
- 18 years and older
- Patients who discharge At Own Risk (AOR) without outcome data
Trial locations and contacts
19 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 9 countries
Malaysia8 sites, 8 recruiting
- Not yet recruiting
Hospital Pulau Pinang
George Town
Pon Kah Min Dr, pon.kahmin@moh.gov.my
- Not yet recruiting
Hospital Sultanah Aminah Johor Bahru
Johor Bahru
Louise Ngu Dr, louisengu@moh.gov.my
- Recruiting
Hospital Tengku Ampuan Rahimah
Klang
Lee Siew Wah Dr, leesiewwah81@gmail.com
- Not yet recruiting
Hospital Tunku Azizah (Hospital Wanita dan Kanak-Kanak Kuala Lumpur)
Kuala Lumpur
Aznor Fadly Bin Azim Dr, afadly@moh.gov.my
- Not yet recruiting
UKM: Hospital Tunku Ampuan Besar Tuanku Aishah Rohani
Kuala Lumpur
Lee Pei Chuen Dr, peichuen@hctm.ukm.edu.my
- Not yet recruiting
University Malaya Medical Centre (UMMC)
Kuala Lumpur
Chuah Soo Lin Dr, chuahsl@ummc.edu.my
- Not yet recruiting
Hospital Umum Sarawak
Kuching
Kok Juan Loong Dr, jlkok64@gmail.com
- Not yet recruiting
Hospital Sultan Idris Shah
Serdang
Ani Suraya Bt Abd Rani @ Abdul Ghani Dr, dranisuraya@moh.gov.my
Singapore2 sites, 2 recruiting
- Recruiting
KK Women's and Children' Hospital
Singapore, 229899
Shu-Ling Chong, MBBS, MRCPCH, MCI, MPH, 65-63941179, Chong.Shu-Ling@kkh.com.sg
- Recruiting
National University Hospital
Singapore
Seo Woon Li Dr, woon_li_seo@nuhs.edu.sg
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Chang Gong Memorial Hospital
Taipei
Jainn-Jim Dr, lin0227@cgmh.org.tw
- Recruiting
National Taiwan University Hospital
Taipei
Szu-han Chen Dr
szuhan0425@gmail.com
Thailand2 sites, 2 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok
Rujipat Dr, rujipatrs@gmail.com
- Not yet recruiting
Ramathibodi Hospital, Mahidol University
Bangkok
Nattachai Anantasit Dr, nattachai032@hotmail.com
China1 site, 1 recruiting
- Not yet recruiting
Shanghai Children's Medical Center, Shanghai Jiaotong University
Shanghai
Xiang Long Dr, xloix@126.com
Hong Kong1 site, 1 recruiting
- Not yet recruiting
Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
Lawrence Chan Dr, lawrence.cnchan@gmail.com
Pakistan1 site, 1 recruiting
- Not yet recruiting
Aga Khan University
Karachi
Qalab Abbas Dr, qalab.abbas@aku.edu
Saudi Arabia1 site, 1 recruiting
- Not yet recruiting
King Abdullah Specialist Children's Hospital
Riyadh
Yasser Kazzaz Dr, yasser.md@gmail.com
Vietnam1 site, 1 recruiting
- Not yet recruiting
The National Children's Hospital
Hanoi
Phan Huu Phuc Dr, phucph@nch.gov.vn
About this study
Official title: Sepsis Optimal Recognition Toolkit in Children (SORT): An Early Recognition Tool for Children in Asia
This study seeks to develop early recognition tools specially designed for children meeting the Phoenix definition and explore implementation science aspects by investigating facilitators and barriers to adopting Phoenix sepsis criteria in clinical practice. This addresses the critical need for systemic, evidence-based approaches to paediatric sepsis identification across diverse healthcare settings in Asia.
Read the detailed description
SPECIFIC AIMS AND HYPOTHESES Specific Aim 1: Among children < 18 years old with suspected infection hospitalised in participating Pediatric Acute \& Critical Care Medicine Asian Network sites, the investigators seek to compare mortality risk among those with a Phoenix sepsis score of ≥ 2 against those with a score < 2.
Hypothesis 1: The investigators hypothesize that that in-hospital mortality (%) will increase at least 5-times in both higher-resource and lower-resource sites when children with suspected infection have a Phoenix sepsis score of ≥ 2 (compared to those with a score of <2). This is based on published Phoenix data.
Specific Aim 2: The investigators aim to derive and validate the Sepsis Optimal Recognition Toolkit in children (SORT) among children (< 18 years old) with suspected infection in both higher-resource and lower-resource sites in the Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN).
Hypothesis 2: The investigators hypothesize that SORT will perform with a sensitivity of 90% and a c-statistic of at least 0.80 in predicting for sepsis as defined by a Phoenix Sepsis Score ≥ 2.
Specific Aim 3: The investigators seek to understand the feasibility and acceptability of implementing the Phoenix criteria across PACCMAN sites.
Hypothesis 3: The investigators hypothesize that the parameters required by the Phoenix sepsis score will be feasible and that clinicians and patients will find it acceptable to apply in routine practice.
Exploratory Aim: The investigators aim to study the mimickers of sepsis among children < 18 years old with a Phoenix sepsis score of ≥ 2.
Hypothesis (Exploratory): The investigators hypothesize that children with tissue hypoperfusion from cardiac, hypovolemia and toxicology causes will fulfil Phoenix criteria and mimic sepsis.
- Being tested
- Application of the Phoenix Sepsis Score
- Keywords
- Phoenix sepsis score, early recognition, infection, child
- Medical subject headings
- Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the Phoenix Sepsis ScoreOther
Data Variables in the first 24 hours of hospital admission as per Phoenix Sepsis Score: Including that of respiratory function (PaO2:FiO2 and SpO2:FiO2 ratios, need for oxygen, high-flow, non-invasive or mechanical ventilation support), cardiovascular function (including need for vasoactive medications, lactate value and mean arterial pressure), coagulopathy (measured using platelets, International Normalized Ratio, D-dimer and Fibrinogen), neurologic dysfunction (measured with Glasgow Coma Scale and presence of fixed pupils), endocrine (blood glucose), immunologic (absolute neutrophil and absolute lymphocyte count), renal (creatinine levels) and hepatic (total bilirubin and alanine transaminase). Data from the Emergency Departments will need to be linked to inpatient records to obtain the worst values in each domain that occurred in the first 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | ARM 1: Retrospective cohort study of children hospitalised with suspected infection from 1st January 2020 to 31st December 2025, among participating sites of the Pediatric Acute \& Critical Care Medicine Asian Network (PACCMAN). Receives: Other: Application of the Phoenix Sepsis Score | |
| Prospective Cohort | ARM 2: Prospective cohort study of children hospitalised with suspected infection from 1st February 2026 to 30th June 2028, among participating sites of the Pediatric Acute \& Critical Care Medicine Asian Network (PACCMAN) Receives: Other: Application of the Phoenix Sepsis Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under the receiver operating characteristic curve (AUROC).
Measured: 2 years
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under precision recall curve (AUPRC).
The investigators will also measure the performance using sensitivity, specificity, positive and negative predictive values.
Measured: 2 years
Derivation of an early recognition tool called Sepsis Optimal Recognition Toolkit in children (SORT)
Following the second specific Aim, the outcome is for the model SORT to be derived with a sensitivity of 90% and a c-statistic of at least 0.80 in predicting for sepsis as defined by a Phoenix Sepsis Score ≥ 2.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Feb 2026
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Other
- Enrolment
- 40,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Responsible party
- Principal investigator, Chong Shu-Ling, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397689
- Sponsor's protocol ID
- 2023-2640
- Other IDs
- HCSAINV25jan-0001
- Acronym
- SORT
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data dictionaries, aggregate data and analytical plan can be shared with investigators who submit their requests to the Responsible Party with a reasonable request.
Publications
Arabi YM, Alsaawi A, Alzahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Vishwakarma RK, Al Anazi R, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Alatassi A, Al-Dorzi HM, Al-Hameed F, Babakr R, Alghamdi AA, Bin Salih S, Alharbi A, AlKatheri ME, Mustafa H, Al-Qahtani S, Al Qahtani S, Alselaim N, Tashkandi N, Alyami AH, Alyousef Z, AlDibasi O, Al-Qahtani AH, Aldawood A, Caswell A, Al Ayadhi N, Al Rehaili H, Al Arfaj A, Al Mubarak H, Alwasaidi T, Zahrani S, Alalawi Y, Alhadab A, Nasser T, Omer T, Al Johani SM, Alajlan A, Sadat M, Alzunitan M, Al Mohrij S; SCREEN Trial Group and the Saudi Critical Care Trials Group. Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial. JAMA. 2025 Mar 4;333(9):763-773. doi: 10.1001/jama.2024.25982.
PubMed 39658862Sanchez-Pinto LN, Bennett TD, DeWitt PE, Russell S, Rebull MN, Martin B, Akech S, Albers DJ, Alpern ER, Balamuth F, Bembea M, Chisti MJ, Evans I, Horvat CM, Jaramillo-Bustamante JC, Kissoon N, Menon K, Scott HF, Weiss SL, Wiens MO, Zimmerman JJ, Argent AC, Sorce LR, Schlapbach LJ, Watson RS; Society of Critical Care Medicine Pediatric Sepsis Definition Task Force; Biban P, Carrol E, Chiotos K, Flauzino De Oliveira C, Hall MW, Inwald D, Ishimine P, Levin M, Lodha R, Nadel S, Nakagawa S, Peters MJ, Randolph AG, Ranjit S, Souza DC, Tissieres P, Wynn JL. Development and Validation of the Phoenix Criteria for Pediatric Sepsis and Septic Shock. JAMA. 2024 Feb 27;331(8):675-686. doi: 10.1001/jama.2024.0196.
PubMed 38245897Schlapbach LJ, Weiss SL, Bembea MM, Carcillo JA, Leclerc F, Leteurtre S, Tissieres P, Wynn JL, Zimmerman J, Lacroix J; Pediatric Organ Dysfunction Information Update Mandate (PODIUM) Collaborative. Scoring Systems for Organ Dysfunction and Multiple Organ Dysfunction: The PODIUM Consensus Conference. Pediatrics. 2022 Jan 1;149(1 Suppl 1):S23-S31. doi: 10.1542/peds.2021-052888D.
PubMed 34970683Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
PubMed 31954465Watson RS, Carrol ED, Carter MJ, Kissoon N, Ranjit S, Schlapbach LJ. The burden and contemporary epidemiology of sepsis in children. Lancet Child Adolesc Health. 2024 Sep;8(9):670-681. doi: 10.1016/S2352-4642(24)00140-8.
PubMed 39142741Schlapbach LJ, Watson RS, Sorce LR, Argent AC, Menon K, Hall MW, Akech S, Albers DJ, Alpern ER, Balamuth F, Bembea M, Biban P, Carrol ED, Chiotos K, Chisti MJ, DeWitt PE, Evans I, Flauzino de Oliveira C, Horvat CM, Inwald D, Ishimine P, Jaramillo-Bustamante JC, Levin M, Lodha R, Martin B, Nadel S, Nakagawa S, Peters MJ, Randolph AG, Ranjit S, Rebull MN, Russell S, Scott HF, de Souza DC, Tissieres P, Weiss SL, Wiens MO, Wynn JL, Kissoon N, Zimmerman JJ, Sanchez-Pinto LN, Bennett TD; Society of Critical Care Medicine Pediatric Sepsis Definition Task Force. International Consensus Criteria for Pediatric Sepsis and Septic Shock. JAMA. 2024 Feb 27;331(8):665-674. doi: 10.1001/jama.2024.0179.
PubMed 38245889
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis Optimal Recognition Toolkit in Children (SORT): An Early Recognition Tool for Children in Asia
- ClinicalTrials.gov ID
- NCT07397689
- Acronym / sponsor ID
- SORT / 2023-2640
- Keywords
- Phoenix sepsis score, early recognition, infection, child
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to develop early recognition tools specially designed for children meeting the Phoenix definition and explore implementation science aspects by investigating facilitators and barriers to adopting Phoenix sepsis criteria in clinical practice. This addresses the critical need for systemic, evidence-based approaches to paediatric sepsis identification across diverse healthcare settings in Asia.
Detailed description
SPECIFIC AIMS AND HYPOTHESES Specific Aim 1: Among children < 18 years old with suspected infection hospitalised in participating Pediatric Acute \& Critical Care Medicine Asian Network sites, the investigators seek to compare mortality risk among those with a Phoenix sepsis score of ≥ 2 against those with a score < 2.
Hypothesis 1: The investigators hypothesize that that in-hospital mortality (%) will increase at least 5-times in both higher-resource and lower-resource sites when children with suspected infection have a Phoenix sepsis score of ≥ 2 (compared to those with a score of <2). This is based on published Phoenix data.
Specific Aim 2: The investigators aim to derive and validate the Sepsis Optimal Recognition Toolkit in children (SORT) among children (< 18 years old) with suspected infection in both higher-resource and lower-resource sites in the Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN).
Hypothesis 2: The investigators hypothesize that SORT will perform with a sensitivity of 90% and a c-statistic of at least 0.80 in predicting for sepsis as defined by a Phoenix Sepsis Score ≥ 2.
Specific Aim 3: The investigators seek to understand the feasibility and acceptability of implementing the Phoenix criteria across PACCMAN sites.
Hypothesis 3: The investigators hypothesize that the parameters required by the Phoenix sepsis score will be feasible and that clinicians and patients will find it acceptable to apply in routine practice.
Exploratory Aim: The investigators aim to study the mimickers of sepsis among children < 18 years old with a Phoenix sepsis score of ≥ 2.
Hypothesis (Exploratory): The investigators hypothesize that children with tissue hypoperfusion from cardiac, hypovolemia and toxicology causes will fulfil Phoenix criteria and mimic sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Other: Application of the Phoenix Sepsis ScoreARM 1: Retrospective cohort study of children hospitalised with suspected infection from 1st January 2020 to 31st December 2025, among participating sites of the Pediatric Acute \& Critical Care Medicine Asian Network (PACCMAN). |
| Prospective Cohort | – | Other: Application of the Phoenix Sepsis ScoreARM 2: Prospective cohort study of children hospitalised with suspected infection from 1st February 2026 to 30th June 2028, among participating sites of the Pediatric Acute \& Critical Care Medicine Asian Network (PACCMAN) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children < 18 years old with suspected infection. Suspected infection is defined as children who undergo blood cultures and receive broad-spectrum anti-microbial agents in the first 24 hours of admission. Anti-microbial agents include antibiotics, antiviral, antifungal and antimalarial medications.
Key inclusion criteria (2 listed)
- Children < 18 years old
- Suspected infection defined by (1) blood culture performed (irrespective of result), AND (2) use of broad-spectrum anti-microbial agents, in the first 24 hours of admission
Key exclusion criteria (2 listed)
- 18 years and older
- Patients who discharge At Own Risk (AOR) without outcome data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of the Phoenix Sepsis ScoreData Variables in the first 24 hours of hospital admission as per Phoenix Sepsis Score: Including that of respiratory function (PaO2:FiO2 and SpO2:FiO2 ratios, need for oxygen, high-flow, non-invasive or mechanical ventilation support), cardiovascular function (including need for vasoactive medications, lactate value and mean arterial pressure), coagulopathy (measured using platelets, International Normalized Ratio, D-dimer and Fibrinogen), neurologic dysfunction (measured with Glasgow Coma Scale and presence of fixed pupils), endocrine (blood glucose), immunologic (absolute neutrophil and absolute lymphocyte count), renal (creatinine levels) and hepatic (total bilirubin and alanine transaminase). Data from the Emergency Departments will need to be linked to inpatient records to obtain the worst values in each domain that occurred in the first 24 hours. | Other | Prospective Cohort, Retrospective Cohort |
Primary outcome
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Time frame: 2 years
Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under the receiver operating characteristic curve (AUROC).
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Time frame: 2 years
Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under precision recall curve (AUPRC). The investigators will also measure the performance using sensitivity, specificity, positive and negative predictive values.
Derivation of an early recognition tool called Sepsis Optimal Recognition Toolkit in children (SORT)
Time frame: 2 years
Following the second specific Aim, the outcome is for the model SORT to be derived with a sensitivity of 90% and a c-statistic of at least 0.80 in predicting for sepsis as defined by a Phoenix Sepsis Score ≥ 2.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 39658862Arabi YM, Alsaawi A, Alzahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Vishwakarma RK, Al Anazi R, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Alatassi A, Al-Dorzi HM, Al-Hameed F, Babakr R, Alghamdi AA, Bin Salih S, Alharbi A, AlKatheri ME, Mustafa H, Al-Qahtani S, Al Qahtani S, Alselaim N, Tashkandi N, Alyami AH, Alyousef Z, AlDibasi O, Al-Qahtani AH, Aldawood A, Caswell A, Al Ayadhi N, Al Rehaili H, Al Arfaj A, Al Mubarak H, Alwasaidi T, Zahrani S, Alalawi Y, Alhadab A, Nasser T, Omer T, Al Johani SM, Alajlan A, Sadat M, Alzunitan M, Al Mohrij S; SCREEN Trial Group and the Saudi Critical Care Trials Group. Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial. JAMA. 2025 Mar 4;333(9):763-773. doi: 10.1001/jama.2024.25982.
- Background: PubMed 38245897Sanchez-Pinto LN, Bennett TD, DeWitt PE, Russell S, Rebull MN, Martin B, Akech S, Albers DJ, Alpern ER, Balamuth F, Bembea M, Chisti MJ, Evans I, Horvat CM, Jaramillo-Bustamante JC, Kissoon N, Menon K, Scott HF, Weiss SL, Wiens MO, Zimmerman JJ, Argent AC, Sorce LR, Schlapbach LJ, Watson RS; Society of Critical Care Medicine Pediatric Sepsis Definition Task Force; Biban P, Carrol E, Chiotos K, Flauzino De Oliveira C, Hall MW, Inwald D, Ishimine P, Levin M, Lodha R, Nadel S, Nakagawa S, Peters MJ, Randolph AG, Ranjit S, Souza DC, Tissieres P, Wynn JL. Development and Validation of the Phoenix Criteria for Pediatric Sepsis and Septic Shock. JAMA. 2024 Feb 27;331(8):675-686. doi: 10.1001/jama.2024.0196.
- Background: PubMed 34970683Schlapbach LJ, Weiss SL, Bembea MM, Carcillo JA, Leclerc F, Leteurtre S, Tissieres P, Wynn JL, Zimmerman J, Lacroix J; Pediatric Organ Dysfunction Information Update Mandate (PODIUM) Collaborative. Scoring Systems for Organ Dysfunction and Multiple Organ Dysfunction: The PODIUM Consensus Conference. Pediatrics. 2022 Jan 1;149(1 Suppl 1):S23-S31. doi: 10.1542/peds.2021-052888D.
- Background: PubMed 31954465Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.
- Background: PubMed 39142741Watson RS, Carrol ED, Carter MJ, Kissoon N, Ranjit S, Schlapbach LJ. The burden and contemporary epidemiology of sepsis in children. Lancet Child Adolesc Health. 2024 Sep;8(9):670-681. doi: 10.1016/S2352-4642(24)00140-8.
- Background: PubMed 38245889Schlapbach LJ, Watson RS, Sorce LR, Argent AC, Menon K, Hall MW, Akech S, Albers DJ, Alpern ER, Balamuth F, Bembea M, Biban P, Carrol ED, Chiotos K, Chisti MJ, DeWitt PE, Evans I, Flauzino de Oliveira C, Horvat CM, Inwald D, Ishimine P, Jaramillo-Bustamante JC, Levin M, Lodha R, Martin B, Nadel S, Nakagawa S, Peters MJ, Randolph AG, Ranjit S, Rebull MN, Russell S, Scott HF, de Souza DC, Tissieres P, Weiss SL, Wiens MO, Wynn JL, Kissoon N, Zimmerman JJ, Sanchez-Pinto LN, Bennett TD; Society of Critical Care Medicine Pediatric Sepsis Definition Task Force. International Consensus Criteria for Pediatric Sepsis and Septic Shock. JAMA. 2024 Feb 27;331(8):665-674. doi: 10.1001/jama.2024.0179.
- Individual participant dataSharing planned: Yes. Data dictionaries, aggregate data and analytical plan can be shared with investigators who submit their requests to the Responsible Party with a reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Sepsis, run by KK Women's and Children's Hospital at 19 sites in 9 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Malaysia, Singapore, Taiwan, Thailand, China and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chong Shu-Ling Dr, MBBS, MRCPCH, MCI, MPH (65 -81211519, Chong.Shu-Ling@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia (time frame: 2 years). The study lists 3 primary outcomes in all. 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 NCT07397689, which also lists 6 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 7 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.