A Randomized, Open Label, Multicentre Phase Iv Study To Evaluate The Efficacy And Safety Of Magnex (Cefoperazone-Sulbactam) In Comparison With Ceftazidime Plus Amikacin And Metronidazole In The Treatment Of Intra-Abdominal Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 307
- 试验地点
- 21
- 主要终点
- Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
研究概览
简要总结
Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside and metronidazole are often used to treat such infections in surgical settings. An alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections. The combination of ceftazidime, amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of Gram-negative and anaerobic organisms found in such conditions.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged greater or equal to 12 years
- •Intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening
- •Presence of at least three of the following five indicators consistent with intra-abdominal infections (Fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation)
- •Written informed consent obtained
排除标准
- •Rapidly progressive illness or critically ill subjects
- •Pregnant or lactating women, or women of childbearing potential not using an effective method of contraception.
- •Treatment with a presumably effective systemic antimicrobial agent for >24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator)
结局指标
主要结局
Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
Physical examination findings.
次要结局
- The proportion of clinical efficacy
- evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;
- proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome
- success or presumed success) at the end of study treatment,
- Total duration of study treatment
- Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.