A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 主要终点
- comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure
研究概览
简要总结
The primary outcome measure is to compare efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults in clinical and biological cure.
The cure rate will be evaluated at the second visit (14 days after the inclusion visit)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recovering of written and dated informed consent form
- •Social Security medical cover
- •Left Iliac Fossa (LIF) pain
- •Moderate fever (>37.8°C)
- •Sensitivity/defence during LIF palpation
- •Biological results :
- •CRP > 10mg/L
- •NFS > 10G/L
- •Neutrophil Granulocytosis > 75%
- •Radiological results - presence to the scan :diverticul & pericolic infiltration
排除标准
- •Patients treated by antibiotherapy in the last 15 days prior inclusion
- •Patients treated by morphinic drug
- •Patients treated by anticoagulant drug
- •Pregnant or breast-feeding women
- •Patients presenting allergy to active principal, to galactose
- •Patients having taking part in another study in the last 3 months prior inclusion
- •Patients unable to comply with the study requirements
- •Patients presenting Chronic affection inconsistent with the study
- •Patients presenting high fever
- •Patients presenting abdominal contracture
- •Patients presenting immunosuppression
- •Radiological sign of complication (abscess>3cm)
- •Patients presenting Pathology inconsistent with efficacy evaluatio
研究组 & 干预措施
Amoxicillin-Clavulanic Acid
3g (3 doses of 1g) of Amoxicillin-Clavulanic acid during 10 days
干预措施: Amoxicillin-Clavulanic Acid (Drug)
Secnidazol-Ciprofloxacin
2g(single dose) of Secnidazol associated with 1g(2 doses of 500mg)of Ciprofloxacin during 3 days
干预措施: Secnidazole, ciprofloxacine (Drug)
结局指标
主要结局
comparaison of the efficacy of an association of Secnidazol(2g)-Ciprofloxacin(1g) (during 3 days) versus 3g of Amoxicillin-Clavulanic Acid during 10 days for clinical and biological cure
时间窗: the cure rate will be evaluated at the second visit (14 days after the inclusion visit)
次要结局
未报告次要终点