Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT04698057
Eligibility Criteria:
Inclusion Criteria:
* Patient ≥ 18 years old
* Treated for a solid cancer or a hematological malignancy
* Presented with low-risk\* febrile neutropenia due to chemotherapy with an expected duration of neutropenia ≤ 7 days
* Neutropenia is defined by an absolute neutrophil count ≤ 500/mm3.
* Fever is defined by temperature ≥ 38.3° or ≥ 38° twice during a 1-hour interval.
* Signing informed consent \*Low risk is defined by MASCC score ≥ 21
Exclusion Criteria:
* Hypersensitivity to the active substances: amoxicillin-clavulanic, ciprofloxacin, penicillins, to other quinolones or to one of the excipient
* History of severe immediate hypersensitivity reaction to another beta-lactam
* History of jaunditis/hepatic impairment related to amoxicillin/clavulanic
* Concomitant administration of ciprofloxacin and tizanidine.
* Clinical signs of focal infection including history of untreated dental abscess.
* Signs of sepsis or organ failure.
* Severe immune deficiency other than the current cancer, except controlled-HIV infection
* Gastrointestinal symptoms requiring intravenous treatment (mucositis, vomiting, severe diarrhea...).
* Known aminotransferase serum levels \> 5 x normal values.
* Known renal insufficiency defined as creatinine clearance of \< 30 mL/min (MDRD).
* Antibiotherapy within 24h before enrollment. Prophylactic use of amoxicillin is an exclusion criterium whereas prophylactic use of trimethoprim-sulfamethoxazole (cotrimoxazole) and penicillin G (Oracilline®) are not and will be considered in the analysis.
* History of infection or colonization due to bacteria resistant to experimental drugs in the previous year
* Can be enrolled in the study only once.
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party.
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies
* Pregnant or breastfeeding women, women at age to procreate and not using effective contraception (either hormonal / mechanical : oral, injection, subcutaneous, implantable, intrauterine device, or surgical : tubal ligation, hysterectomy, total ovariectomy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT04698057
Study Brief:
Protocol Section:
NCT04698057