Early Sepsis Recognition Tool

NCT07397689 | Not Yet Recruiting DMC

• 2 other identifiers: 2023-2640HCSAINV25jan-0001
• Study Type: observational
• Target: 40,000
• Locations: 9 countries
• Sites: 19

Brief 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. This addresses the critical need for systemic, evidence-based approaches to paediatric sepsis identification across diverse healthcare settings in Asia.

Conditions

Infection; Sepsis

Keywords

Phoenix sepsis score; early recognition; infection; child

Outcome Measures

Primary Outcomes (3)

• 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).

  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). We will also measure the performance using sensitivity, specificity, positive and negative predictive values.

  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.

  2 years

Study Arms (2)

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).

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)

Other: Application of the Phoenix Sepsis Score

Interventions

Application of the Phoenix Sepsis Score OTHER

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.

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• years and older
• Patients who discharge At Own Risk (AOR) without outcome data

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (19)

Shanghai Children's Medical Center, Shanghai Jiaotong University

Shanghai, China

Location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Hospital Pulau Pinang

George Town, Malaysia

Location

Hospital Sultanah Aminah Johor Bahru

Johor Bahru, Malaysia

Location

Hospital Tengku Ampuan Rahimah

Klang, Malaysia

Location

Hospital Tunku Azizah (Hospital Wanita dan Kanak-Kanak Kuala Lumpur)

Kuala Lumpur, Malaysia

Location

UKM: Hospital Tunku Ampuan Besar Tuanku Aishah Rohani

Kuala Lumpur, Malaysia

Location

University Malaya Medical Centre (UMMC)

Kuala Lumpur, Malaysia

Location

Hospital Umum Sarawak

Kuching, Malaysia

Location

Hospital Sultan Idris Shah

Serdang, Malaysia

Location

Aga Khan University

Karachi, Pakistan

Location

King Abdullah Specialist Children's Hospital

Riyadh, Saudi Arabia

Location

KK Women's and Children' Hospital

Singapore, 229899, Singapore

Location

National University Hospital

Singapore, Singapore

Location

Chang Gong Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Ramathibodi Hospital, Mahidol University

Bangkok, Thailand

Location

The National Children's Hospital

Hanoi, Vietnam

Location

Related Publications (6)

• 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.

  PMID: 39658862 BACKGROUND

• Sanchez-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.

  PMID: 38245897 BACKGROUND

• Schlapbach 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.

  PMID: 34970683 BACKGROUND

• Rudd 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.

  PMID: 31954465 BACKGROUND

• Watson 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.

  PMID: 39142741 BACKGROUND

• Schlapbach 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.

  PMID: 38245889 BACKGROUND

MeSH Terms

Conditions

Infections; Sepsis

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chong Shu-Ling Dr, MBBS, MRCPCH, MCI, MPH

CONTACT

65 -81211519; Chong.Shu-Ling@kkh.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Start Date: December 2028 End Date: December 2029
• Access Criteria: Researchers should submit the request to the Responsible Party listed in this study. Data dictionaries, aggregate data and analytical plan can be shared.

Locations

HK (1); SA (1); MY (8); CN (1); VN (1); TH (2); TW (2); SG (2); PA (1)