Dynamic Infection Kinetics for Early Diagnosis, Monitoring, and Prognostication of Sepsis in Adult Oncology Patients: Evaluating Serial Infection Biomarkers, Blood Culture Kinetics, Treatment Response, Disease Severity, and Clinical Outcomes

Sponsor
Sohag University
Study ID
NCT07795502
Status
Recruiting
Apply to this trial

Conditions

  • Sepsis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Dynamic Infection Kinetics as an Early Diagnostic and Monitoring Tool for Sepsis in Oncology Patients This study aims to evaluate whether changes over time in infection-related biomarkers and blood culture findings can help detect sepsis earlier and monitor the response to treatment in adult patients with cancer. Cancer patients are at increased risk of developing serious infections and sepsis because of their underlying disease and its treatment. Early diagnosis and monitoring can be challenging because the signs and laboratory findings of infection may be nonspecific. This prospective observational cohort study will include adult oncology patients with suspected sepsis who have at least one blood culture collected as part of their routine medical care. Clinical, laboratory, and microbiological information will be collected, including blood culture results, causative microorganisms, time to blood culture positivity, blood culture clearance time, C-reactive protein (CRP), procalcitonin (PCT), presepsin, absolute neutrophil count, serum lactate, and clinical severity measures. Patients will be followed during hospitalization and for up to 30 days after enrollment. The study will assess whether changes in these markers over time are associated with treatment response, persistent infection, complications, intensive care admission, and mortality. The findings may help identify patients at higher risk of poor outcomes and may contribute to improved monitoring and management of sepsis in patients with cancer.

Key Dates

First listed
Aug 31, 2026
Start date
Jul 15, 2026
Status verified
Aug 2026
Primary completion
Mar 7, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Oncology Patients with Suspected Sepsis
    Adult oncology patients with suspected sepsis who have at least one blood culture obtained as part of routine clinical care. Participants will be followed during hospitalization and for up to 30 days after enrollment. Clinical, laboratory, and microbiological data will be collected to evaluate dynamic infection kinetics and their association with treatment response and clinical outcomes.

Primary Outcome Measure

30-day all-cause mortality [ Time Frame: Within 30 days after enrollment ]

Related Studies