Fast-track blood test for suspected neutropenic fever in cancer patients
Fast-track Absolute Neutrophil Count in Suspected Neutropenic Fever (The FRANCiS-NF Trial): A Single-centre, Pragmatic, Open-label, Randomised, Controlled Trial
This study tests a quick blood test for cancer patients with suspected neutropenic fever to see if it helps doctors decide when to start antibiotics right away.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 344 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05393505 on ClinicalTrials.gov |
What this trial studies
This study evaluates a fast-track clinical pathway for adult cancer patients presenting with suspected neutropenic fever in the emergency department. It aims to determine the necessity of immediate antibiotic treatment by comparing blood test results with clinical outcomes. Participants will receive a blood test to assess neutrophil levels and will be monitored for infection-related complications. The goal is to reduce unnecessary antibiotic use and improve patient management in emergency settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with cancer who present with a fever and have recently undergone chemotherapy or targeted therapy.
Not a fit: Patients with severe infections, such as sepsis or central nervous system infections, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more appropriate antibiotic use and better outcomes for patients with neutropenic fever.
How similar studies have performed: Other studies have explored similar fast-track approaches in emergency settings, indicating potential for success in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Hong Kong
- Queen Mary Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Timothy Hudson Rainer, MBBCh; MRCP — Department of Emergency Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong
- Study coordinator: Timothy Hudson Rainer, MBBCh; MRCP
- Email: thrainer@hku.hk
- Phone: +852-93133096
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.