An observational study in Infection and Sepsis, sponsored by KK Women's and Children's Hospital. Recruiting at 19 sites in 9 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by KK Women's and Children's Hospital · Observational
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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.
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.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
This study's planned enrollment of 40,000 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →KK Women's and Children's Hospital is the lead sponsor of 137 studies on the registry; 33 are open to participants now.
Compared within Sepsis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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Exclusion Criteria:
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
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
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.
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).
Time frame: 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.
Time frame: 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.
Time frame: 2 years
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
Started Feb 2026 (actual). Primary completion is estimated for Jun 2028, 28 months after the start.
Of 492 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 28 months is close to that.
Counting every sponsor, half of 544 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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