A Phase 2 Randomized, Double-blind, Double-dummy Efficacy, Safety And Tolerability Study Of Iv Sulopenem With Switch To Oral Pf-03709270 Compared To Ceftriaxone With Step Down To Amoxicillin/Clavulanate Potassium (Augmentin) In Subjects With Community Acquired Pneumonia (Cap) Requiring Hospitalization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 35
- 试验地点
- 21
- 主要终点
- Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit
研究概览
简要总结
The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized male or female patients 18 years of age or older.
- •Female patients of childbearing potential must not be pregnant.
- •Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia.
- •Must require hospitalization for the pneumonia.
- •Chest Xray must be suggestive of a pneumonia.
排除标准
- •Hospital or ventilator associated pneumonia.
- •Patients with cystic fibrosis, pneumocystis carinii pneumonia or active tuberculosis.
- •Previous treatment for the current pneumonia episode received for more than 24 hours.
- •Allergies to penems or beta lactams.
研究组 & 干预措施
1
Loading dose of IV sulopenem with switch to oral PF-03709270
干预措施: Sulopenem and PF-03709270 (Drug)
2
IV sulopenem with switch to oral PF-03709270
干预措施: Sulopenem and PF-03709270 (Drug)
3
IV ceftriaxone with switch to oral amoxicillin/clavulanate potassium comparator
干预措施: Ceftriaxone and amoxicillin/clavulanate (Drug)
结局指标
主要结局
Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit
时间窗: 7 to 14 days after end of treatment
Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment \[EOT\]) CR was evaluated as "cure"=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; "failure"=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell \[WBC\] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; "indeterminate"=extenuating circumstances precluded classification to 1 of the above.
次要结局
- Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit(Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT))
- Number of Participants With Microbiological Response at Test of Cure (TOC) Visit(7 to 14 days after EOT)
- Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit(EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT))