Ongoing Clinical Trials for Febrile Neutropenia
There are currently 2 ongoing clinical trials exploring new treatment approaches for febrile neutropenia, a serious condition characterized by fever and dangerously low white blood cell counts. These studies are investigating whether shorter antibiotic treatments can be as safe and effective as longer courses, potentially reducing side effects and antibiotic resistance. The trials are taking place in Belgium and France, focusing on patients receiving chemotherapy for blood-related cancers.
Clinical trial locations
- Belgium
- France
Study on Shortening Antibiotic Treatment for Febrile Neutropenia in Hematology Patients Using Cefepime and Drug Combination
This trial, conducted in Belgium, aims to determine whether a shorter course of antibiotic treatment is as safe and effective as a longer one for patients with high-risk febrile neutropenia. The condition occurs when patients undergoing treatment for blood-related diseases develop a fever along with dangerously low levels of neutrophils, which are white blood cells essential for fighting infections.
Main inclusion criteria: Participants must be older than 16 years and provide written informed consent. They must have started intensive therapy within three days before joining the study for conditions such as newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or be preparing for stem cell transplantation. Patients must have an expected neutrophil count below 0.5×10⁹/L lasting 7 days or more and be expected to remain hospitalized for at least 10 days.
Main exclusion criteria: Patients without febrile neutropenia cannot participate. Those outside the specified age range or not part of the designated clinical trial groups are also excluded. The trial does not accept participants considered part of a vulnerable population who might be at higher risk of harm.
Focus and goal: The study compares stopping antibiotics after three days versus continuing them for a longer period. Researchers will monitor participants for up to 42 days, tracking serious medical complications such as the need for intensive care, development of severe infections, duration of hospital stays, and changes in antibiotic use. The goal is to minimize antibiotic use while maintaining patient safety, which could help reduce antibiotic resistance and side effects.
Investigational drugs: The trial uses several broad-spectrum antibiotics including cefepime, imipenem, piperacillin, ceftazidime, and meropenem. These medications are delivered directly into a vein through intravenous infusion. Some participants will receive a placebo after the initial treatment period to test the effectiveness of the shortened antibiotic course.
Comparing amoxicillin-clavulanate alone versus amoxicillin-clavulanate with ciprofloxacin for treating chemotherapy-induced fever in adult hematology patients
This French study focuses on adult patients with blood disorders such as lymphoma, myelodysplasia, and acute myeloblastic leukemia who develop fever after chemotherapy. The trial compares two oral antibiotic treatment approaches for patients who can be treated outside the hospital setting.
Main inclusion criteria: Participants must be at least 18 years old and have one of three blood disorders being treated with specific therapies: lymphoma being treated for remission, myelodysplasia being treated with azacytidine, or acute myeloblastic leukemia being treated with non-intensive therapy. They must be expected to have neutropenia lasting less than 7 days due to chemotherapy. Patients need to understand study information, participate in phone calls, complete follow-up forms, provide written consent, and be covered by a welfare care system.
Main exclusion criteria: The trial excludes patients with a history of neutropenia lasting more than 7 days, previous infection episodes during chemotherapy, or severe allergic reactions to the study antibiotics. Patients with kidney or liver problems affecting medication metabolism, those currently taking other antibiotics, pregnant or breastfeeding women, and those under 18 years cannot participate. Patients unable to take oral medications, those with severe infections requiring immediate hospitalization, participants in other trials, those unable to provide informed consent, or with known resistance to study antibiotics are also excluded.
Focus and goal: The study examines whether amoxicillin-clavulanate alone works as effectively as combining it with ciprofloxacin. Patients receive treatment for 7 days and are followed for 30 days. Researchers track fever resolution, whether hospital admission becomes necessary, fever recurrence, and side effects including joint pain, tendon pain, confusion, heart rhythm changes, and allergic reactions. Regular phone calls and assessments occur at 48 hours, day 4, day 14, and day 30.
Investigational drugs: The trial uses amoxicillin-clavulanate, a combination antibiotic containing amoxicillin (which kills bacteria) and clavulanate (which prevents bacterial resistance). This is compared with a combination of amoxicillin-clavulanate plus ciprofloxacin, a fluoroquinolone antibiotic that stops bacterial growth by interfering with DNA replication. Both treatments are taken by mouth, making them suitable for patients who don’t need hospital admission.
Summary
Both ongoing trials represent important efforts to optimize antibiotic treatment for febrile neutropenia in patients receiving chemotherapy for blood-related cancers. A key theme across both studies is investigating whether shorter or simpler antibiotic regimens can maintain safety while reducing unnecessary medication use. The Belgian trial focuses on hospitalized patients with high-risk, long-lasting neutropenia, testing whether three days of intravenous antibiotics is sufficient. The French trial targets patients with shorter-expected neutropenia who can be treated at home, comparing whether adding ciprofloxacin to amoxicillin-clavulanate provides additional benefit. These studies reflect a broader medical goal of fighting antibiotic resistance by avoiding unnecessarily long or complex antibiotic treatments. Both trials use different antibiotics appropriate to their settings: intravenous broad-spectrum antibiotics for hospitalized patients and oral antibiotics for outpatient care. The geographic distribution shows research activity in Western Europe, with each country contributing one trial focused on different patient populations and treatment settings.
