Fast-track Blood Test for Suspected Fever by Deficiency of a Kind of White Blood Cells As Main Defense Against Infection (FRANCiS-NF)
Neutropenic Fever
About this trial
This is an interventional treatment trial for Neutropenic Fever focused on measuring febrile neutropenia, emergency department, cancer, adult, sepsis, randomized controlled trial, antibiotic stewardship, clinical laboratory services, chemotherapy, hematopoietic stem cell transplantation
Eligibility 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
Sites / Locations
- Queen Mary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Fast-tRack Absolute Neutrophil Count (FRANC) Protocol
Standard of Care
Patient's blood sample will be expedited for complete blood count with differentials. Intravenous antibiotic is given depending on absolute neutrophil count. If neutropenia is present, broad-spectrum antibiotic (meropenem 1 g or levofloxacin 500 mg) will be given after septic workup within 1 hour of registration in emergency department before transfer to wards. If absent, antibiotic according to "Hospital Authority Interhospital Multi-disciplinary Programme on Antimicrobial ChemoTherapy (IMPACT)" with reference to previous bacterial sensitivity pattern, or amoxiclav 1.2 g if not specified, will be given. Other interventions are given according to clinical needs. The regimen is continued until clinicians recommend an alternative antimicrobial based on clinical grounds, or detection of other pathogens which indicate another antimicrobial.
The control group refers to the existing clinical pathway which guides management of adult patients with suspected NF in ED. Without information of absolute neutrophil count, Meropenem 1 g IV bolus (or Levofloxacin 500 mg IV infusion over 1 hour if Penicillin-allergic) will be given within 1 hour of ED registration after septic workup. Other interventions are given according to clinical needs. Subsequent treatment in wards will be determined by doctor's clinical judgement, on a personalised basis. Each patient will be assessed by a parent team member. There is no standardised antibiotic de-escalation protocol in place, but it is a usual practice to continue Meropenem or Levofloxacin injections until clinical improvement, rising ANC, and negative culture results. After that it will be replaced with an antibiotic with a narrower spectrum, such as oral Amoxiclav, before discharge.