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Antibiotic

Short Antibiotic Treatment for Febrile Neutropenia

N/A
Recruiting
Led By Shahid Husain, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years and older
Patient has acute leukemia (AML, ALL or mixed-phenotypic acute leukemia) and is undergoing induction, re-induction or salvage chemotherapy or undergoing allogeneic HSCT and receiving conditioning chemotherapy and/or radiation
Must not have
Septic shock at the onset of the episode or 72 hours
Patients with febrile neutropenia secondary to specific treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test if shorter antibiotic treatment for cancer patients with low neutrophil counts is as safe as longer treatment. Prolonged antibiotic use may lead to more infections with drug-resistant bacteria

Who is the study for?
This trial is for adults over 18 with acute leukemia or undergoing stem cell transplant, who have low neutrophil counts due to treatment and develop a fever without any documented infection. They must have had negative blood cultures after antibiotics for at least 72 hours.
What is being tested?
The study compares the safety of stopping antibiotics early versus the standard longer treatment in cancer patients with febrile neutropenia. It aims to determine if shorter treatments can prevent complications from drug-resistant bacteria and other infections.
What are the potential side effects?
Potential side effects may include an increased risk of life-threatening infections if antibiotics are stopped too soon, as well as complications from multi-drug-resistant bacteria, C. difficile infections, and fungal infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am receiving treatment for acute leukemia, including chemotherapy or a stem cell transplant.
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I have had a fever with very low white blood cells as per IDSA guidelines.
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I do not have any infections confirmed by clinical or lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experienced septic shock at the start or within 72 hours of my current health issue.
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I have had a fever and low white blood cell count due to treatment.
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I am getting my initial chemotherapy or stem cell transplant as an outpatient.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence
Complete outcome data
Recruitment
Secondary study objectives
Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) analysis
Development of an antibiotic resistant infection or colonization
Rate of Clostridioides difficile associated diarrhea
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Short treatmentExperimental Treatment1 Intervention
Antibiotic treatment will be stopped at the time of allocation to the intervention group
Group II: Prolonged treatmentActive Control1 Intervention
Antibiotic treatment will be continued until the resolution of neutropenia (ANC \> 0.5x109/L)

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,524 Previous Clinical Trials
503,124 Total Patients Enrolled
Shahid Husain, MDPrincipal InvestigatorUniversity Health Network, Toronto
2 Previous Clinical Trials
60 Total Patients Enrolled
~40 spots leftby Dec 2025
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