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Study Comparing Fosfomycin and Ciprofloxacin for Preventing Fever in Patients with Acute Leukemia After Chemotherapy or Stem Cell Transplant

Verified siteRegistered drugNo placebo

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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 a condition known as febrile neutropenia, which often occurs in patients with acute leukemia who are undergoing intensive chemotherapy or receiving a hematopoietic stem cell transplant. Febrile neutropenia is a serious condition characterized by a fever and a low number of neutrophils, a type of white blood cell that helps fight infections. The study aims to compare the effectiveness and safety of two antibiotics, fosfomycin and ciprofloxacin, in preventing this condition.

Participants in the study will be randomly assigned to receive either fosfomycin or ciprofloxacin. Both medications are taken orally, meaning they are swallowed in pill form. The study will monitor the participants over a period of time to see how well each medication works in preventing febrile neutropenia and to ensure the safety of the participants. The goal is to determine if fosfomycin is as effective as ciprofloxacin in preventing infections in these patients.

The study is designed to help improve treatment options for patients with acute leukemia who are at high risk of developing infections due to their weakened immune systems. By comparing these two antibiotics, researchers hope to find the best approach to prevent febrile neutropenia and improve the overall care for patients undergoing chemotherapy or stem cell transplants.

The research process

The trial runs in 4 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 be randomly assigned to receive either fosfomycin or ciprofloxacin. These are medications taken by mouth to help prevent infections during your treatment.
You will be informed about the specific medication you will receive and its purpose in the study.
Step 2
Medication administration
If you are assigned to fosfomycin, you will take it as prescribed by the study team. The dosage and frequency will be explained to you in detail.
If you are assigned to ciprofloxacin, you will also take it as prescribed. The study team will provide you with the necessary instructions regarding dosage and frequency.
Step 3
Monitoring and follow-up
Throughout the study, your health will be closely monitored. This includes regular check-ups to assess your response to the medication and to ensure your safety.
You will be required to report any side effects or changes in your health to the study team promptly.
Step 4
End of study participation
Your participation in the study will conclude when your neutrophil count, a type of white blood cell, reaches a certain level, or after 60 days from the start of your neutropenia, whichever comes first.
The study may also end if you begin a new cycle of chemotherapy or if other specific conditions outlined by the study are met.

Who can join the trial?

16 criteria

Participants must be able to understand the study procedures, follow them, and provide written consent before any study-related activities.
Participants must be adults aged 18 or older with a diagnosis of acute leukemia who are about to receive their first chemotherapy treatment or are candidates for a first stem cell transplant.
Participants should have an expected low level of a type of white blood cell called neutrophils, lasting at least seven days. If the expected range is between 100-500, they must have at least one of the following risk factors for infection:
Expected severe mouth sores (grade 3-4 mucositis).
Age 65 years or older.
A comorbidity index (HCTI) of 3 or more, which is a measure of other health conditions.
Low levels of a protein in the blood called serum albumin, less than 35 g/L.
A total dose of a chemotherapy drug called etoposide greater than 500 mg/m².
A total dose of a chemotherapy drug called cytarabine greater than 1 g/m².
Active or difficult-to-treat cancer at the time of stem cell transplantation.
Participants should have a performance status of 0 to 3, which is a measure of their ability to carry out daily activities.
Participants must have adequate organ function, meaning:
Liver function: Levels of bilirubin, alkaline phosphatase, or SGOT should be less than 3 times the normal limit, unless related to tumor activity.
Kidney function: Creatinine levels should be 250 μmol/L (2.5 mg/dL) or less, unless related to acute myeloid leukemia (AML) activity.
Participants should have a life expectancy of more than 3 months.
Women of childbearing age should not be pregnant or breastfeeding and must have a negative pregnancy test at the time of screening. Both women of childbearing age and men with female partners of childbearing age must agree to use two highly effective birth control methods and agree not to become pregnant or father a child during the study and for at least 3 months after treatment ends.

Who cannot join the trial?

6 criteria

Patients who are not at high risk of developing an infection after chemotherapy.
Patients who do not have acute leukemia.
Patients who are not undergoing intensive chemotherapy.
Patients who are not receiving a type of treatment called hematopoietic stem cell transplantation, which is a procedure to replace damaged or destroyed bone marrow with healthy bone marrow stem cells.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Clinico San Carlos
Verified
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain

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Investigated drugs

Fosfomycin
is an antibiotic used in this trial to prevent infections in patients with weakened immune systems, such as those undergoing treatment for acute leukemia. It works by stopping the growth of bacteria, helping to prevent febrile neutropenia, a condition where a patient has a fever and a low number of neutrophils, a type of white blood cell important for fighting infections.
Ciprofloxacin
is another antibiotic being tested in the trial. It is used to prevent bacterial infections in patients with acute leukemia who are at risk of developing febrile neutropenia. Ciprofloxacin works by killing bacteria or preventing their growth, thereby helping to protect patients with compromised immune systems from infections.

What is already known about the treatment

Fosfomycin
Fosfomycin is administered orally and is currently being studied in clinical trials for its effectiveness in preventing febrile neutropenia in patients with acute leukemia undergoing intensive chemotherapy or hematopoietic stem cell transplantation. It is being compared to ciprofloxacin to assess its non-inferiority in efficacy. Fosfomycin is primarily used to treat bacterial infections and works by inhibiting bacterial cell wall synthesis, which ultimately leads to the death of the bacteria. It is classified as an antibiotic.
Ciprofloxacin
Ciprofloxacin is an oral medication being evaluated in clinical trials for its role in preventing febrile neutropenia in patients with acute leukemia receiving intensive chemotherapy or hematopoietic stem cell transplantation. It is being compared to fosfomycin to determine its effectiveness. Ciprofloxacin is commonly used to treat various bacterial infections by inhibiting bacterial DNA gyrase, which prevents bacterial replication. It belongs to the class of antibiotics known as fluoroquinolones.

Investigated diseases

Post-chemotherapy neutropenia – This condition occurs when the number of neutrophils, a type of white blood cell, drops significantly after chemotherapy. Neutrophils are crucial for fighting infections, so their reduction increases the risk of infections. It is particularly concerning in patients with acute leukemia undergoing treatments like induction therapy or stem cell transplantation. The condition progresses as the neutrophil count remains low, making the body more susceptible to infections. Patients may experience fever and other signs of infection due to the weakened immune system. Monitoring and supportive care are essential to manage the risks associated with this condition.