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Identifying early risk of severe infection in children with blood cancers and fever with low immunity using tests and computer analysis

Early risk stratification and prediction of progression to sepsis and septic shock in pediatric febrile neutropenia associated with hematolymphoid malignancies using machine learning and biomarker integration - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/07/114005
Enrollment
126
Registered
2026-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C920- Acute myeloblastic leukemia

Interventions

Intervention1: Nil: Nil

Sponsors

Balaji Suhruth Padakanti
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 18 years or younger diagnosed with hemato lymphoid malignancy Febrile neutropenia defined as Single oral temperature greater than or equal to 38.3 degrees Celsius or greater than or equal to 38.0 degrees Celsius sustained for more than 1 hour Absolute neutrophil count less than 500 cells per cubic millimeter or expected to fall below 500 within the next 48 hours Presentation within 24 hours of onset of fever

Exclusion criteria

Exclusion criteria: Patients who have received antibiotics within 24 hours prior to presentation Children with pre existing autoimmune or metabolic disorders that may interfere with biomarker or metabolomic analysis

Design outcomes

Primary

MeasureTime frame
Identification of clinical and laboratory patterns predictive of progression to sepsis and septic shock in paediatric febrile neutropenia Timepoint: all the available outcomes data will be collected at 0, 24 and 48hr after the FN episode—

Secondary

MeasureTime frame
Development & validation of paediatric specific risk prediction score by integrating clinical patterns & presepsin dynamics. Timepoint: Presepsin levels will be assessed at 0hr, 24hr, & 48hr timepoints after the FN episode.—

Countries

India

Contacts

Public ContactBalaji Suhruth

Kasturba medical college ,MAHE, Manipal.

ravi.maradi@manipal.edu

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026