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NCT07901660
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Conditions: Suspected Neutropenic Fever, Confirmed Neutropenic Fever, Severe Neutropenic Fever, Neutropenic Fever, Febrile Neutropenia, Febrile Neutropenia (FN), Neutropenia, Neutropenia (Low White Blood Cell Count)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 317
Sponsor: The University of Hong Kong
Location: Queen Mary Hospital Hong Kong
Summary
Study 1 (S1). In a range of adult patients with sNF and controls, there is no significant difference between the POC-ANC and laboratory analyser.
The diagnostic study will be performed 24 hours a day. Informed consent will be sought from every patient for a finger prick (capillary blood) and venous blood sample.
Briefly, paired capillary (finger prick) and venous EDTA blood samples will be obtained from 317 patients meeting the inclusion criteria.
Prospective diagnostic accuracy study. The target accuracy index is the lower 95%CI of sensitivity, although we evaluate other important factors of diagnostic accuracy (see data analysis below).
Eligibility Criteria
Inclusion Criteria:
1. ≥18 years; AND
2. Suspected low ANC; AND
3. Stable.
Exclusion Criteria:
1. No consent obtained
2. Blood sampling my hinder the management of the patient according to the doctor or nurse.
Source: ClinicalTrials.gov (NCT07901660). StuddyBuddy aggregates publicly available trial information.
