Status:
UNKNOWN
Fast-track Blood Test for Suspected Fever by Deficiency of a Kind of White Blood Cells As Main Defense Against Infection
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Queen Mary Hospital, Hong Kong
Conditions:
Neutropenic Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a comparative study for adult participants with cancer who are suspected to have neutropenic fever (or fever with low neutrophil count) in emergency department. Neutrophil is a kind of defensi...
Detailed Description
1\. Background 1.a. Burden of neutropenic fever Neutropenic fever (NF), or febrile neutropenia, is characterised by high body temperature and low absolute neutrophil count (ANC) following myelosuppre...
Eligibility Criteria
Inclusion
- Age criteria: 18 years old or above; AND
- Body temperature criteria: Tympanic temperature ≥ 38.3 degree Celsius (100.9 degree Fahrenheit) within 24 hours before emergency department registration; AND
- Chemotherapy timeframe criteria: Last chemotherapy or targeted therapy within 6 weeks for any solid tumor, or in any period following therapies against leukemia, lymphoma, myelodysplastic syndrome, aplastic anemia, multiple myeloma, or recipient of hematopoietic stem cell transplantation; AND
- Modified Early Warning Score (MEWS) ≤ 4
Exclusion
- Unable to provide informed consent
- Previous enrolment to this trial within 180 days, or without current resolution of the first episode
- Enrolment to other interventional trials within 187 days
- Sepsis or septic shock
- Suspected central nervous system infection
- Severe desaturation (SpO2 \< 88% in room air for patients with chronic obstructive pulmonary disease, severe chest wall or spinal disease, neuromuscular disease, severe obesity, cystic fibrosis, bronchiectasis; or \< 94% in room air without)
- Currently on prophylactic antibiotic
- Any antibiotic treatment for \> 48 h within 1 week
- Known human immunodeficiency virus infection
- Primary humoral immunodeficiency
- Complement deficiency
- Asplenia
- Vulnerable subjects (illiterate, pregnancy, mentally incapacitated, impoverished, prisoner, subordinate or students of investigators, ethnic minorities)
- Research staff not available
- Unable to randomize within 1 hour of emergency department registration
- Inter-hospital transfer
- Scheduled "clinical" admissions
- Body temperature not documented
- Blood sample not taken in emergency department
Key Trial Info
Start Date :
October 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
344 Patients enrolled
Trial Details
Trial ID
NCT05393505
Start Date
October 24 2022
End Date
June 30 2025
Last Update
December 6 2022
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong