Status:
WITHDRAWN
Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial.
Lead Sponsor:
Poitiers University Hospital
Conditions:
Febrile Neutropenia
Eligibility:
All Genders
18-110 years
Phase:
PHASE3
Brief Summary
In low risk neutropenic fever in cancer, standard of care is the association of amoxicillin clavulanate and ciprofloxacin. But in this population, the rate of fever related to infection is very low, l...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04698057
Start Date
March 1 2022
End Date
June 1 2025
Last Update
March 31 2022
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