NCT00887276终止4 期
Prospective, Doubleblind, Randomized Multicenter Study to Proof the Clinical and Bacteriological Non-inferiority of Ampicillin/Amoxicillin Versus Moxifloxacin in Hospitalized Patients With Non-severe Community-acquired Pneumonia
University of Ulm8 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 290
- 试验地点
- 8
- 主要终点
- Proof of the clinical non inferiority by the cure rate at the treatment of a Pneumonia at the therapy end (round 3: Day 7 to 10) with a standard penicillin in a high dosage
研究概览
简要总结
The purpose of this study is to prove the clinical and bacteriological non-inferiority of ampicillin/amoxicillin versus moxifloxacin in hospitalized patients with non-severe community-acquired pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women older than 18 years with signed informed consent
- •Women in a childbearing age with sufficient conception protection or if necessary negative pregnancy test
- •Infiltrates appeared newly in the x-ray thorax
- •Breath-conditioned chest pain
- •At least two of the following clinical symptoms of a pneumonia:
- •cough which is newly appeared or increasing,
- •mucopurulent or purulent sputum,
- •fever (body temperature >= 37.8 degrees Celsius auricalary and/or >= 38,3°C rectal), positive auscultation
- •Negative legionella antigen test in the urine
- •CRB-65-Index < 3
排除标准
- •Hospitalization within the last 28 days (except for the last 72 h)
- •Participation in another therapy study within the last 4 weeks with studies admission
- •intake of an antibiotic longer than 24 hrs within the last 72 hours before studies admission
- •Patients in the pregnancy and nursing phase
- •Existence of contraindications opposite the examining preparations or other B-Lactam antibiotics or fluorochinolons
- •Patients with a CURB-Index >= 3
- •Patients with suspicion of retrostenotic Pneumonia because of bronchial obstruction
- •Patients with suspicion of nosocomial Pneumonia
- •Patients with an infection by a known or suspected resistant pathogene
研究组 & 干预措施
Moxifloxacin
Active Comparator
干预措施: Moxifloxacin (Drug)
Ampicillin; Amoxicillin
Active Comparator
干预措施: Ampicillin;Amoxicillin (Drug)
结局指标
主要结局
Proof of the clinical non inferiority by the cure rate at the treatment of a Pneumonia at the therapy end (round 3: Day 7 to 10) with a standard penicillin in a high dosage
时间窗: after at least 7 days, i.e., at the time of round 3 (therapy end)
次要结局
- clinical cure rate(at round 4 (follow-up: day 28 to 35))
- bacteriological sensitivity into-vitro(at round 4 (follow-up: day 28 to 35))
- time up to the drug-switch(at round 4 (follow-up: day 28 to 35))
- bacteriological effectiveness on patients and seed level(at round 4 (follow-up: day 28 to 35))
- time until the dismissal of the patients necessity of the gift of additional antibacterial drug(at round 4 (follow-up: day 28 to 35))
- assessment of the effectiveness by the investigator(at round 4 (follow-up: day 28 to 35))
- cost reduction of the antibiotic-therapy and the complete treatment(at round 4 (follow-up: day 28 to 35))
研究者
研究点 (8)
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