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Efficacy of an empirical treatment with Amoxicillin-clavulanate (AC) compared to the combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the outpatient care of chemotherapy-induced fever in adult haematology patients. AC-CIF Protocol
EU CTIS ID: 2025-520995-24-00
What this study is testing
To demonstrate the non-inferiority of amoxicillin-clavulanate (AC) compared to the reference combination treatment amoxicillin-clavulanate and ciprofloxacin (AC+C), in the empirical oral outpatient treatment of a first episode of CIF in adult haematology patients.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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)
- • Written informed consent
- • Affiliated to or beneficiary of the welfare care
- • 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))
You likely can't join if
- Patient under legal protection
- Previous treatment with CAR-T cells
- Previous allogeneic or autogeneic bone-marrow transplantation
- Chronic obstructive pulmonary disease (COPD)
- Previous invasive fungal infection
- Allergy to one of the study medications
See the full eligibility criteria
- • 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)
- • Written informed consent
- • Affiliated to or beneficiary of the welfare care
- • 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))
- Patient under legal protection
- Previous treatment with CAR-T cells
- Previous allogeneic or autogeneic bone-marrow transplantation
- Chronic obstructive pulmonary disease (COPD)
- Previous invasive fungal infection
- Allergy to one of the study medications
- Contraindication to fluoroquinolones: a) 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), b) treatment with tizanidine, c) previous hypersensitivity to any quinolone, d) previous tendonitis attributed to any fluoroquinolone, e) epilepsy
- Contraindication to amoxicillin-clavulanate
- QT prolongation (defined as a QT interval > 0.45 seconds for males and > 0.47 seconds for females)
- Antibiotic prophylaxis (with the exception of the combination sulfamethoxazole and trimethoprim)
- Pregnant or breastfeeding women
- Patient deprived of liberty by judicial or administrative decision
- Women not using contraception
- Patient treated with anti-psychotic drug
- 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…
- Participation in another interventional clinical trial
- Impossible collection of informed consent (including non-francophone patient, or cognitive disorders)
- Body mass index (BMI) > 30
- Basal neutrophils count < 1000/mm3 (on the latest available blood test performed < 1 month before inclusion)
- Aminotransferase serum levels > 5 X normal values (on the latest available blood test performed < 1 month before inclusion)
- Creatinine clearance < 30 mL/min (on the latest available blood test performed < 1 month before inclusion)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.