Could one antibiotic replace two for chemo fevers? major trial launches
NCT ID NCT07483736
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a single antibiotic (amoxicillin-clavulanate) against the standard two-drug combination (amoxicillin-clavulanate plus ciprofloxacin) for treating fever caused by chemotherapy in adults with certain blood cancers. The goal is to see if the simpler treatment works just as well, while reducing side effects and antibiotic resistance. About 1,500 participants will be randomly assigned to one of the two treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,526 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients (≥ 18 years) with one of the following haematological disorders (in whom chemotherapy regimens are expected to provoke neutropenia lasting \<7 days) (1) lymphoma of all histological types treated with the goal of remission; (2) myelodysplasia treated with azacytidine; (3) acute myeloblastic leukaemia, treated with a non-intensive scheme (azacytidine, azacytidine+venetoclax, other oral treatment against molecular targets) 2. Written informed consent 3. Patient able to understand all information related to the study and able to follow the protocol procedures (phone call and completion of the patient follow-up form (electronic or paper)) 4. Affiliated to or beneficiary of the welfare care Exclusion Criteria: * 1\. Patient under legal protection 2. Patient deprived of liberty by judicial or administrative decision 3. Patient who is the investigator, any member of the study team, or a relative directly involved in the trial, including assistant physicians, pharmacists, study coordinators, etc… 4. Participation in another interventional clinical trial 5. Impossible collection of informed consent (including non-francophone patient, or cognitive disorders) 6. Body mass index (BMI) \> 30 7. Basal neutrophils count \< 1000/mm3 (on the latest available blood test performed \< 1 month before inclusion) 8. Aminotransferase serum levels \> 5 X normal values (on the latest available blood test performed \< 1 month before inclusion) 9. Creatinine clearance \< 30 mL/min (on the latest available blood test performed \< 1 month before inclusion) 10. Previous treatment with CAR-T cells 11. Previous allogeneic or autogeneic bone-marrow transplantation 12. Chronic obstructive pulmonary disease (COPD) 13. Previous invasive fungal infection 14. Allergy to one of the study medications 15. Contraindication to fluoroquinolones: 1. hypersensitivity to ciprofloxacin, to other quinolones, or to any of the following excipients (microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, titanium dioxide), 2. treatment with tizanidine, 3. previous hypersensitivity to any quinolone, 4. previous tendonitis attributed to any fluoroquinolone, 5. epilepsy 16. Contraindication to amoxicillin-clavulanate 17. QT prolongation (defined as a QT interval \> 0.45 seconds for males and \> 0.47 seconds for females) 18. Antibiotic prophylaxis (with the exception of the combination sulfamethoxazole and trimethoprim) 19. Pregnant or breastfeeding women, 20. Women not using contraception 21. Patient treated with anti-psychotic drug
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CH Jacques Coeur
Bourges, France
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CH Poissy Saint-Germain-en-Laye
Poissy, France
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CH de BRIVE LA GAILLARDE
Brive-la-Gaillarde, France
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CH de Perigueux
Périgueux, France
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CH de SAINT NAZAIRE
Saint-Nazaire, France
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CH de SAUMUR
Saumur, France
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CH de Valence
Valence, France
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CH de Versailles
Le Chesnay, France
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CHU Caen-Normandie
Caen, France
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CHU d'ORLEANS
Orléans, France
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CHU de SAINT-ETIENNE
Saint-Priest-en-Jarez, France
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Groupe Hospitalier Haute Saône Vesoul
Vesoul, France
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Hopital Necker Enfants Malade
Paris, France
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Hopital Saint Louis
Paris, France
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Hopital de La Pitie Salpetriere
Paris, France
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Institut Curie
Saint-Cloud, France
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