EUCTR2020-003159-13-FR进行中（未招募）1 期
Amoxicillin-clavulanate alone or in combination with Ciprofloxacin in Low-Risk Febrile Neutropenic adult Patients: A Prospective, Double-blind, Randomized, Non-InferiorityMulticenter, Phase III Clinical Trial - ACACIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient = 18 years old.
- •- Treated for a solid cancer or a hematological malignancy.
- •- Presented with low-risk febrile neutropenia (low risk is defined by MASCC score = 21) 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.
- •- Patient affiliated to an appropriate health insurance.
- •- Signing informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- 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,...).
- •- Known aminotransferase serum levels > 5 x normal values
- •- Know 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.
研究者
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