Not yet recruiting

Comparing amoxicillin-clavulanate alone versus amoxicillin-clavulanate with ciprofloxacin for treating chemotherapy-induced fever in adult hematology patients

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on treating chemotherapy-induced fever in adult patients with hematological disorders such as lymphoma, myelodysplasia, and acute myeloblastic leukemia. The purpose is to compare two different antibiotic treatments in patients who develop fever after receiving chemotherapy. The treatments being studied are amoxicillin-clavulanate alone versus a combination of amoxicillin-clavulanate with ciprofloxacin.

The study examines how well these antibiotic treatments work in patients who can receive care outside the hospital. The medications are taken by mouth, and the treatment period lasts for 7 days. During this time, patients will be monitored to see if their fever goes away and if they experience any other health issues.

Patients will be followed for 30 days after starting treatment. The main focus is to determine if using amoxicillin-clavulanate alone works as effectively as using it together with ciprofloxacin. The study will track various aspects of patient health, including whether the fever returns, if hospital admission becomes necessary, and any side effects from the medications.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment assignment
You will be assigned to receive either amoxicillin-clavulanate alone or amoxicillin-clavulanate plus ciprofloxacin
Both medications are taken by mouth
The treatment begins when you first experience fever after chemotherapy
Step 2
First 48 hours
You will receive a phone call to check your condition
The medical team will verify if you needed to go to the hospital
Your vital status will be assessed
Step 3
Day 4 assessment
Your temperature will be measured to check if the fever has gone away
The medical team will verify if any changes to your antibiotic treatment were needed
Your overall health status will be evaluated
Step 4
Days 1-7 monitoring
You will need to keep track of how well you follow the prescribed treatment
Complete a treatment compliance form each day
Step 5
Day 14 follow-up
You will receive a phone call to assess your condition
The medical team will review your medical records
They will check if you experienced any fever recurrence
Your blood test results will be reviewed
Any side effects will be documented, including: joint pain, tendon pain, confusion, heart rhythm changes, allergic reactions
Step 6
Day 30 final assessment
You will receive a final phone call
The medical team will check if you needed any hospital stays
Your overall health status will be evaluated one last time

Who can join the trial?

9 criteria

Must be at least 18 years old
check
Must have one of these blood disorders:
- Lymphoma (cancer of the lymphatic system) being treated to achieve remission
- Myelodysplasia (bone marrow disorder) being treated with azacytidine
- Acute myeloblastic leukemia (blood cancer) being treated with non-intensive therapy
- Expected to have neutropenia (low white blood cell count) lasting less than 7 days due to chemotherapy
- check
  Must be able to understand study information and follow study procedures, including:
  - Participating in phone calls
  - Completing follow-up forms (electronic or paper)
  - Must provide written consent to participate in the study
  - Must be covered by welfare care system

Who cannot join the trial?

12 criteria

Previous history of neutropenia (a condition where there are abnormally low levels of white blood cells) lasting more than 7 days
Patients who have already experienced episodes of infection during chemotherapy
Patients with severe allergic reactions to amoxicillin-clavulanate or ciprofloxacin (antibiotics used in the study)
Patients with kidney or liver problems that could affect the metabolism of study medications
Patients currently taking other antibiotics
Pregnant or breastfeeding women
Patients under 18 years of age
Patients who cannot take oral medications
Patients with severe infections requiring immediate hospital treatment
Patients participating in other clinical trials
Patients unable to provide informed consent
Patients with known resistance to study antibiotics

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Centre Hospitalier De Perigueux
Perigueux, France
Verified
Centre Hospitalier De Versailles
Le Chesnay-Rocquencourt, France

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Amoxicillin-clavulanate is an antibiotic combination medication that fights bacterial infections. It contains amoxicillin, which kills bacteria, and clavulanate, which helps the amoxicillin work better by preventing bacteria from becoming resistant to it. This medication is commonly used to treat various types of bacterial infections. Ciprofloxacin is an antibiotic that belongs to a group called fluoroquinolones. It works by stopping the growth of bacteria and is effective against many different types of bacterial infections. This medication is often used to treat infections in patients with weakened immune systems. The trial compares using Amoxicillin-clavulanate alone versus using it in combination with Ciprofloxacin for treating fever in patients receiving chemotherapy. Both treatments are given by mouth to patients who don't need to stay in the hospital.

What is already known about the treatment

Amoxicillin-clavulanate
An oral antibiotic combination medication consisting of amoxicillin (a penicillin-type antibiotic) and clavulanic acid, which helps prevent bacterial resistance. This medication works by stopping the growth of bacteria by interfering with their cell wall formation, and is commonly used to treat various bacterial infections. It belongs to the class of beta-lactam antibiotics combined with beta-lactamase inhibitors, making it effective against a broader spectrum of bacteria than amoxicillin alone.
Ciprofloxacin
A broad-spectrum antibiotic medication taken orally that belongs to the fluoroquinolone class of antibiotics. It works by interfering with bacteria's DNA replication process, effectively stopping bacterial growth and multiplication. The medication is commonly used to treat various bacterial infections, particularly those caused by gram-negative bacteria, and is especially effective in treating respiratory, urinary, and systemic infections. When combined with amoxicillin-clavulanate, it provides enhanced coverage against a wider range of bacterial pathogens, particularly useful in treating infections in immunocompromised patients.

Investigated diseases

Neutropenia
A condition where there is an abnormally low count of neutrophils, a type of white blood cell essential for fighting infections. It commonly occurs as a side effect of chemotherapy treatments in cancer patients. During neutropenia, the body's ability to combat bacterial infections is significantly reduced. The condition can develop rapidly after chemotherapy administration and may last for several days. Neutropenia makes patients more susceptible to various infections, particularly bacterial ones.
Chemotherapy-induced Fever
A rise in body temperature that occurs as a complication during cancer treatment with chemotherapy drugs. The fever typically develops when the patient's immune system is weakened by the treatment. This condition often appears during periods of low white blood cell counts. The fever may occur with or without an identifiable infection source. It represents one of the most common complications in patients receiving chemotherapy.