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

NCT07795502 | Recruiting

• 1 other identifier: Soh-Med-26-7-29MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Keywords

Oncology patients; Early diagnosis; Infection kinetics; Procalcitonin

Outcome Measures

Primary Outcomes (1)

• 30-day all-cause mortality

  Within 30 days after enrollment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Oncology Center

Sohag, Sohag Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator of Medical Microbiology & Immunology

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): March 7, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)