Short Antibiotic Treatment in High Risk Febrile Neutropenia
ConditionFebrile Neutropenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
Infections are a common complication in patients with cancer. They are a significant cause of complications and death in this population. Patients with cancer and low neutrophil counts due to chemotherapy or disease often have a fever and receive antibiotic treatment. The optimal duration of this treatment is largely unknown. Late, there have been some data suggesting the safety of early discontinuation of antibiotics, though most centers still give more prolonged antibiotic therapies in this situation. The unnecessary prolonged antibiotic use may increase infections with multi-drug-resistant bacteria, which carry a high death rate. Also, an increase in infections caused by Clostridioides difficile and an increase in fungal infections can happen. However, some are concerned that stopping antibiotics while the neutrophil count is still low will result in life-threatening infections. Our study aims to test whether shorter antibiotic treatment in these situations is as safe as more prolonged treatment, resulting in better antibiotic prescription practices in this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and older.
The patient either 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.
Single oral temperature of ≥38.3°C or at least two measurements of ≥38.0°C in an interval of ≥1 hour.
ANC ≤ 0.5x109/L.
Disqualifiers
Concurrent participation in another interventional trial.
The patient has received empirical antibiotics for more than seven days from the onset of the febrile neutropenic episode.
Septic shock at the onset of the episode or 72 hours (defined as persisting hypotension requiring vasopressors to maintain a MAP ≥ 65 mmHg and having a serum lactate level > 2 mmol/L despite adequate volume resuscitation).
Patients with febrile neutropenia secondary to the treatment for solid malignancies, autologous HSCT, CAR-T cell therapy, hematologic malignancies besides acute leukemia when not in the context of allogeneic HSCT, AML treated with consolidation chemotherapy, or ALL treated with intensification and maintenance phase of chemotherapy.
Trial design
Design model
Parallel
Treatments tested in this trial
Early Discontinuation of Antibiotics
Other interventionAntibacterial treatment (i.e piperacillin/tazobactam, ceftazidime, cefepime, meropenem, vancomycin, amikacin, tobramycin, ciprofloxacin) will be stopped after 72 hours of treatment and defervescence for 24 hours, irrespective of neutrophil count
Standard of Care
Other interventionAntibacterial treatment (i.e piperacillin/tazobactam, ceftazidime, cefepime, meropenem, vancomycin, amikacin, tobramycin, ciprofloxacin) will be continued until resolution of neutropenia
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Short treatmentExperimental treatment 1 intervention
Group B: Prolonged treatmentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment
number of patients enroled per site per month
Time frame
through study completion, approximately 2 years2
Adherence
percentage of participants that adhered to the allocated intervention (meaning they stopped antibiotics within 2 days of the intervention they were randomized to)
Time frame
30 days from randomization3
Complete outcome data
percentage of participants that were lost to follow up
Time frame
30 days from randomizationSecondary outcomes
1
Rate of all-cause mortality
All-cause mortality
Time frame
30 days from randomization2
Rate of transfer to the ICU
transfer to the intensive care unit will be derived from the participant's electronic health record
Time frame
30 days from randomization3
Rate of any clinically or microbiologically documented infection
any clinically diagnosed infection (i.e pneumonia, intra-abdominal infection, skin-soft tissue infection when no bacteria was isolated) or any microbiologically documented infection (isolation of a bacteria/fungi from a sterile site with the exception of blood contaminants in a single blood culture or isolation of bacteria/fungi from a non-sterile site accompanied by a clinical syndrome). This will not include viral infections.
Time frame
30 days from randomization4
Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) analysis
DOOR for our study will be (ordinal outcome scale): 1. The participant survived until day 30 without CDI, MDI or being transferred to ICU. 2. The participant had a CDI or MDI but was not transferred to ICU, and they survived. 3. The participant was transferred to ICU but survived. 4. Death.
Time frame
30 days from randomizationSponsors and contacts
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Source ClinicalTrials.gov