Fast-track Blood Test for Suspected Fever by Deficiency of a Kind of White Blood Cells As Main Defense Against Infection

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 defensive white blood cell combating against infection, especially by bacteria and fungi. Low neutrophil can be part of the disease progress or secondary to some cancer treatment. These participants are at high risk of developing infection-related complications including death.

Currently a dedicated clinical pathway has been in place in emergency department for suspected neutropenic fever, which offers fast-track medical consultation, blood tests and a very strong antibiotic (meropenem) as the first choice within 1 hour of registration. However, majority of such participants' neutrophil counts are not low. Most of them have no bacterial infection in the body, and have unremarkable short hospital stays. Early administration of meropenem in the majority of cases may be unnecessary and imposes risk of developing antibiotic resistance.

This study attempts to answer the question, "In adult participants with cancer presenting to emergency department with suspected neutropenic fever, when compared with conventional treatment, can a new protocol guided by fast-track neutrophil count reduces prescription of meropenem?" Agreed participants will be randomly assigned to the conventional treatment group, or the new treatment group. For those who are assigned to the new treatment group, blood will be taken and sent to the hospital laboratory for urgent analysis of neutrophil count. Participants with proven low neutrophil counts will still receive meropenem, while those without low neutrophil counts will receive less strong antibiotic according to their clinical diagnoses, such as Augmentin. They will be followed up on the first 7 days, and then on the 14th, 30th, 90th, and 180th days after recruitment. Comparisons will be made to see how much less meropenem will be prescribed, and whether more serious adverse events will happen. The study is expected to take 37 months to complete. Duration of data collection, including the day of last follow up, is estimated to be 33 months.

Conditions

• Neutropenic Fever

Interventions

DRUG

Meropenem Injection

Given if patient has no known allergies at 1 g IV bolus within 1 hour of ED registration, then every 8 hours

DRUG

Levofloxacin

Given if patient is allergic to beta lactam at 500 g IV in 100 mL 0.9% sodium chloride solution, infused over 1 hour started within 1 hour of ED registration, then every 24 hours. If the patient can tolerate oral drugs, 500 mg daily after the first IV dose.

DRUG

Amoxicillin Clavulanate

Given if patient has no known allergies at 1.2 g IV bolus within 1 hour of ED registration, then every 8 hours. If the patient can tolerate oral drugs, 1 g twice daily after the first IV bolus.

DRUG

Antibiotic

Any antibiotic for empirical therapy of common infections as recommended by the fifth version of "Hospital Authority Interhospital Multi-disciplinary Programme on Antimicrobial ChemoTherapy (IMPACT)" guideline, with reference to previous bacterial sensitivity pattern

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Timothy Hudson Rainer, MBBCh; MRCP · Department of Emergency Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-24

Primary Completion

2025-03-14

Completion

2025-06-30

Countries

• Hong Kong

Study Locations