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Study on Shortening Antibiotic Treatment for Febrile Neutropenia in Hematology Patients Using Cefepime and Drug Combination

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of febrile neutropenia, a condition that often affects patients undergoing treatment for blood-related diseases. Febrile neutropenia is characterized by a fever and a low number of neutrophils, which are a type of white blood cell important for fighting infections. The study will explore the use of several antibiotics, including cefepime, imipenem, piperacillin, ceftazidime, and meropenem, to determine if a shorter course of antibiotic treatment is as effective and safe as a longer course for patients with this condition.

The purpose of the study is to assess whether stopping antibiotics after three days is as safe as continuing them for a longer period in patients with high-risk febrile neutropenia. Participants will receive one of the antibiotics mentioned above, or a placebo, through intravenous infusion, which means the medication is delivered directly into a vein. The study will last up to 42 days, during which the health of the participants will be closely monitored to ensure their safety and to observe any potential complications.

Throughout the study, researchers will look for any serious medical complications, such as the need for intensive care or the development of severe infections. They will also track the occurrence of other infections, the duration of hospital stays, and any changes in the use of antibiotics. The goal is to find a treatment strategy that is both effective and minimizes the use of antibiotics, which can help reduce the risk of antibiotic resistance and other side effects.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will provide written consent to participate. This consent confirms your understanding of the study and your willingness to be part of it.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying your age, medical condition, and treatment history. You must be over 16 years old and undergoing specific treatments for certain blood-related conditions.
Step 3
Randomization
You will be randomly assigned to one of two groups. One group will receive a short course of antibiotics, while the other will receive an extended course. This process is random to ensure unbiased results.
Step 4
Treatment phase
During the treatment phase, you will receive antibiotics through an intravenous (IV) line. The antibiotics used may include cefepime, imipenem, piperacillin, ceftazidime, or meropenem. The specific antibiotic and duration will depend on your assigned group.
Step 5
Monitoring
You will be closely monitored for 42 days after randomization. This monitoring includes checking for any serious medical complications, such as severe infections or the need for intensive care.
Step 6
Follow-up assessments
Regular follow-up assessments will be conducted to track your health status. These assessments will include checking for infections, antibiotic use, and any hospital readmissions.
Step 7
Completion of study
At the end of the study period, a final assessment will be conducted. This will help determine the effectiveness and safety of the short antibiotic treatment strategy.

Who can join the trial?

8 criteria

The participant or their legally authorized representative must provide voluntary written informed consent before any screening procedures. This means they agree to join the study after understanding what it involves.
The participant must be older than 16 years.
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The participant must have started intensive therapy within three days before being randomly assigned to a treatment group for one of the following blood-related conditions:
- Remission induction chemotherapy for newly diagnosed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). This is a treatment to help achieve remission in these blood cancers.
- Re-induction chemotherapy for a relapse after a blood cancer remission that lasted at least 6 months. This is a treatment to help achieve remission again.
- Conditioning regimen to prepare for an allogeneic HCT (hematopoietic cell transplantation). This is a treatment to prepare for a stem cell transplant from a donor.
- Conditioning regimen to prepare for an autologous HCT. This is a treatment to prepare for a stem cell transplant using the patient's own cells.
- The participant is expected to have longstanding neutropenia for 7 days or more. Neutropenia is a condition where there are very low levels of neutrophils, a type of white blood cell important for fighting infections. Specifically, the absolute neutrophil count should be less than 0.5x10⁹/L.
- The participant is expected to stay in the hospital for at least 10 days.

Who cannot join the trial?

5 criteria

Patients who do not have febrile neutropenia cannot participate. Febrile neutropenia is a condition where a person has a fever and a low number of a type of white blood cell called neutrophils, which are important for fighting infections.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
Both male and female patients can participate, but those who do not meet other criteria cannot join.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes people who might be at higher risk of harm or exploitation.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Grand Hopital De Charleroi
Charleroi, Belgium
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Broad-spectrum antibiotic is a type of medication used to treat a wide range of bacterial infections. In this clinical trial, the broad-spectrum antibiotic is given to patients with febrile neutropenia, a condition where a person has a fever and a low number of neutrophils, a type of white blood cell important for fighting infections. The trial aims to see if taking this antibiotic for a shorter period, specifically 72 hours, is as safe and effective as taking it for a longer time. The goal is to determine if patients can safely stop the antibiotic after three days without increasing the risk of complications.

What is already known about the treatment

Broad-spectrum antibiotic – This medication is administered orally or intravenously, depending on the specific needs of the patient. It is currently being studied in clinical trials to determine its effectiveness in treating febrile neutropenia, a condition characterized by fever and low levels of neutrophils, a type of white blood cell, in patients undergoing treatment for blood-related cancers. The main therapeutic indication is to reduce the duration of antibiotic treatment while ensuring safety and effectiveness. At the molecular level, broad-spectrum antibiotics work by targeting and inhibiting essential processes in bacteria, such as cell wall synthesis or protein production, leading to the elimination of a wide range of bacterial infections. These antibiotics are classified pharmacologically as agents that can act against multiple types of bacteria, making them useful in treating infections when the specific bacteria are not yet identified.

Investigated diseases

Febrile neutropenia – Febrile neutropenia is a condition characterized by the development of fever, often as a sign of infection, in a person with neutropenia, which is an abnormally low count of neutrophils, a type of white blood cell. This condition is commonly seen in patients undergoing chemotherapy, as the treatment can significantly reduce white blood cell counts. The progression of febrile neutropenia involves the body's reduced ability to fight infections due to the low number of neutrophils. As the condition advances, patients may experience symptoms such as chills, sweating, and other signs of infection. The risk of developing serious infections increases as the neutrophil count decreases. Monitoring and managing the condition is crucial to prevent complications.