- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07795502
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
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Sohag Governorate
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Sohag, Sohag Governorate, Egypten
- Rekrytering
- Sohag Oncology Center
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Kontakt:
- Esraa Mohamed Abdelraheem, Demonstrator
- Telefonnummer: 0201097937788
- E-post: Esraa_Abdelraheem@med.sohag.edu.eg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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30-day all-cause mortality
Tidsram: Within 30 days after enrollment
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Within 30 days after enrollment
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Soh-Med-26-7-29MS
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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