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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07795502
Enrollment
100
Registered
2026-08-31
Start date
2026-07-15
Completion date
2027-08-15
Last updated
2026-09-01

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

Conditions

Sepsis

Keywords

Oncology patients, Early diagnosis, Infection kinetics, Procalcitonin

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.

Interventions

None listed

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
30-day all-cause mortalityWithin 30 days after enrollment

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026