BridgeMD
New treatment option for Febrile Neutropenia
Official title Short Antibiotic Treatment in High Risk Febrile Neutropenia
ClinicalTrials.gov ID: NCT05786495
What this study is testing
- What it's testing
- Infections are a common complication in patients with cancer. They are a significant cause of complications and death in this population.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Documented febrile neutropenia as defined by the IDSA guidelines [1]:
- 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.
You likely can't join if
- Concurrent participation in another treatment 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...
- Patients with febrile neutropenia secondary to the treatment for solid malignancies, autologous HSCT, CAR-T cell therapy, hematologic malignancies...
- Clinically or microbiologically documented infections except for probable or proven invasive fungal disease diagnosed a-priori and treated.
- Patients receiving their induction chemotherapy or allogeneic HSCT as outpatients.
See the full eligibility criteria
- 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...
- Documented febrile neutropenia as defined by the IDSA guidelines [1]:
- 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.
- Patient without a clinically or microbiologically documented infection (CDI/MDI). We will require the following criteria to rule out infection:
- No focus of infection on a thorough history and physical examination at baseline and daily.
- Negative blood cultures after at least two sets of blood cultures have been taken. For example, the growth of coagulase-negative staphylococci, diphtheroids or Bacillus spp. from a single set will be considered...
- Other cultures will be taken as indicated.
- A negative chest XR or CT scan (which will be performed according to the physician's discretion) for patients with symptoms of cough or chest pain.
- The subject will comply with the following criteria:
- Received empirical antibiotics for at least 72 hours AND
- Is afebrile for at least 24 hours AND
- Is still neutropenic (ANC ≤0.5x109/L).
- Concurrent participation in another treatment 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...
- 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...
- Clinically or microbiologically documented infections except for probable or proven invasive fungal disease diagnosed a-priori and treated.
- Patients receiving their induction chemotherapy or allogeneic HSCT as outpatients.
- We will not allow the enrollment of patients who have been previously enrolled in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Canada
- London, Canada
- Toronto, Canada
- Vancouver, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Canada; London, Canada; Toronto, Canada; Vancouver, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.