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

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What is this study about?

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.

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

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

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

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

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

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 Study?

  • Must be at least 18 years old
  • 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
  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier De Perigueux Perigueux France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Hospitalier Intercommunal De Poissy Saint Germain St Germain En Laye France
Centre Hospitalier Jacques Coeur Bourges France
Centre hospitalier de Saint-Nazaire St Nazaire France
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Ca Gamn Vhydhk Vesoul France
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Igdobxhc Cipfw Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.06.2025

Trial locations

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.

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.

Trial ID:
2025-520995-24-00
Protocol code:
P23/12
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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    Investigated diseases:
    Belgium