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Could one antibiotic replace two for chemo fevers? major trial launches

NCT ID NCT07483736

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,526 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CH Jacques Coeur

    Bourges, France

  • CH Poissy Saint-Germain-en-Laye

    Poissy, France

  • CH de BRIVE LA GAILLARDE

    Brive-la-Gaillarde, France

  • CH de Perigueux

    Périgueux, France

  • CH de SAINT NAZAIRE

    Saint-Nazaire, France

  • CH de SAUMUR

    Saumur, France

  • CH de Valence

    Valence, France

  • CH de Versailles

    Le Chesnay, France

  • CHU Caen-Normandie

    Caen, France

  • CHU d'ORLEANS

    Orléans, France

  • CHU de SAINT-ETIENNE

    Saint-Priest-en-Jarez, France

  • Groupe Hospitalier Haute Saône Vesoul

    Vesoul, France

  • Hopital Necker Enfants Malade

    Paris, France

  • Hopital Saint Louis

    Paris, France

  • Hopital de La Pitie Salpetriere

    Paris, France

  • Institut Curie

    Saint-Cloud, France

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