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

Dynamic Infection Kinetics as an Early Diagnostic and Monitoring Tool for Sepsis in Oncology Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Egypt
  • Sohag Governorate
    • Sohag, Sohag Governorate, Egypt
      • Recruiting
      • Sohag Oncology Center
      • Contact: Esraa Mohamed Abdelraheem, Demonstrator; Phone Number: 0201097937788; Email: Esraa_Abdelraheem@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult patients with solid or hematological malignancies who present with suspected sepsis and 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 to evaluate dynamic infection kinetics and clinical outcomes.

Description

Inclusion Criteria:

• Confirmed diagnosis of a solid or hematological malignancy.
• Clinical suspicion of sepsis according to treating physicians.
• At least one blood culture obtained before or shortly after initiation of antimicrobial therapy.
• Availability for clinical follow-up during hospitalization.

Exclusion Criteria:

• Patients receive palliative care only.
• Absence of blood culture sampling.
• Incomplete clinical or laboratory data.
• Refusal to participate in the study, when applicable.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day all-cause mortality	Within 30 days after enrollment

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2026
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): August 15, 2027

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 31, 2026

Study Record Updates

• Last Update Posted (Actual): September 1, 2026
• Last Update Submitted That Met QC Criteria: August 28, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Procalcitonin; Early diagnosis; Oncology patients; Infection kinetics
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Disease; Sepsis
• Other Study ID Numbers: Soh-Med-26-7-29MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient confidentiality and privacy considerations. Only aggregate study results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No