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.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Success rate
研究概览
简要总结
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, leading to a overtreatment of the patients. The aim of this study is to validate a descalation of the antibiotherapy with safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/mm
- •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
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, 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).
研究组 & 干预措施
Amoxicillin clavulanate + ciprofloxacin
Treatment with amoxicillin-clavulanate 1g tib and ciprofloxacine 750mg bid for 5 days
干预措施: Amoxicillin Clavulanate (Drug)
Amoxicillin clavulanate + ciprofloxacin
Treatment with amoxicillin-clavulanate 1g tib and ciprofloxacine 750mg bid for 5 days
干预措施: Ciprofloxacin (Drug)
Amoxicillin clavulanate + Placebo
Treatment with amoxicillin-clavulanate 1g tib for 5 days
干预措施: Placebo (Drug)
Amoxicillin clavulanate + Placebo
Treatment with amoxicillin-clavulanate 1g tib for 5 days
干预措施: Amoxicillin Clavulanate (Drug)
结局指标
主要结局
Success rate
时间窗: 7 days
The success rate is defined by the proportion of patients receiving the tested regimen: * with resolution of fever ≤72h after the start of antibiotics (total duration of antibiotics expected : 5 days) * AND without any modification of the antibiotic regimen (route, dosage, combination total duration of antibiotics expected : 5 days), * AND without fever recurrence in 48h following the discontinuation of antibiotics (so end of the measure of the main outcome at day 7).
次要结局
未报告次要终点