ciprofloxacin hydrochloride, ciprofloxacin for Febrile neutropenia|Chemotherapy-induced fever|Haematological disorders

Inclusion criteria

• {"criterion_text":"- •\tAdult 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)\n- •\tWritten informed consent\n- •\tAffiliated to or beneficiary of the welfare care\n- •\tPatient 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))"}

Exclusion criteria

• {"criterion_text":"- Patient under legal protection\n- Previous treatment with CAR-T cells\n- Previous allogeneic or autogeneic bone-marrow transplantation\n- Chronic obstructive pulmonary disease (COPD)\n- Previous invasive fungal infection\n- Allergy to one of the study medications\n- 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\n- Contraindication to amoxicillin-clavulanate\n- QT prolongation (defined as a QT interval > 0.45 seconds for males and > 0.47 seconds for females)\n- Antibiotic prophylaxis (with the exception of the combination sulfamethoxazole and trimethoprim)\n- Pregnant or breastfeeding women\n- Patient deprived of liberty by judicial or administrative decision\n- Women not using contraception\n- Patient treated with anti-psychotic drug\n- 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…\n- Participation in another interventional clinical trial\n- Impossible collection of informed consent (including non-francophone patient, or cognitive disorders)\n- Body mass index (BMI) > 30\n- Basal neutrophils count < 1000/mm3 (on the latest available blood test performed < 1 month before inclusion)\n- Aminotransferase serum levels > 5 X normal values (on the latest available blood test performed < 1 month before inclusion)\n- Creatinine clearance < 30 mL/min (on the latest available blood test performed < 1 month before inclusion)"}

Primary endpoints

• {"endpoint_text":"- Clinical success, defined as apyrexia measured 4 days after the first antibiotic dose, without modification of antibiotic treatment","definition_or_measurement_approach":"Clinical success defined as apyrexia measured 4 days after the 1st antibiotic dose, without modification of antibiotic treatment (measurement at Day 4)"}

Secondary endpoints

• {"endpoint_text":"- Clinical criteria: a) Fever recurrence before Day 14 (fever surveillance form Day 1 to Day 14; H48; Day 4; Day 14); b) Hospitalization for treatment failure (H48; Day 4; Day 14, Day 30); c) Hospitalization in intensive care unit for treatment failure (H48; Day 14, Day30); d) Death (Day 14, Day 30) e) Death due to infection (Day 14, Day 30)","definition_or_measurement_approach":"Measured using fever surveillance form Day 1–14 and assessments at H48, Day 4, Day 14 and Day 30; hospitalization and mortality endpoints recorded at specified timepoints"}
• {"endpoint_text":"- Therapeutic criteria: a) Adequacy of empirical antibiotic treatment to the treatment prescribed at randomization (H48; Day 4; Day 14) b) Treatment compliance (treatment compliance surveillance form Day1 to Day 7) c) Any modification in antibiotic treatment (H48; Day 4; Day 14) d) Treatment with a beta-lactam antibiotic with efficacy against P. aeruginosa (Day 14) e) Antibiotic duration (Day 14)","definition_or_measurement_approach":"Adequacy assessed at H48, Day 4, Day 14; compliance via surveillance form Day 1–7; modifications and specific antibiotic therapies recorded at indicated timepoints"}
• {"endpoint_text":"- Microbiological criteria: a) Bacteraemia (in the subgroup of secondarily hospitalized patients) (Day 14) b) Empirical antibiotic treatment inefficient against identified bacteria (in the subgroup of secondarily hospitalized patients) (Day 14) c) Pseudomonas aeruginosa bacteraemia (Day 14)","definition_or_measurement_approach":"Microbiological outcomes assessed using culture results and recorded by Day 14 in hospitalized subgroup"}
• {"endpoint_text":"- Adverses Events: AE and SAE will be collected at every follow-up visit. Eval at H48 by phone call (hospitalization, vital status). Eval at Day 14 by phone call, review of medical charts and retrospective collection of biological and microbiological data (hospitalization, vital status, occurrence of the following events: tendinous pain, joint pain, confusion, QT prolongation, cardiac rhythm disorder, allergy, C. difficile colitis). Eval at Day 30 by phone call (hospit + vital status)","definition_or_measurement_approach":"AEs and SAEs collected at H48 (phone), Day 14 (phone and chart review, retrospective lab/micro data), and Day 30 (phone); specific adverse events listed will be monitored"}

France

Earliest CTIS Part Ii Submission Date

05-06-2025

Latest Decision Or Authorization Date

24-12-2025

Processing Time Days

202

Number Of Sites

17

Number Of Participants

1526

Primary sponsor

Full Name

Centre Hospitalier De Versailles

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France