NCT01726023已完成3 期
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 486
- 试验地点
- 1
- 主要终点
- The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
研究概览
简要总结
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
详细描述
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 to 90 years of age, inclusive,
- •Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy
- •Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose
- •Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
- •Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory indicators; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections
排除标准
- •Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
- •Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
- •Patients whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization
- •Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
- •Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
研究组 & 干预措施
Ceftazidime-Avibactam plus metronidazole
Experimental
干预措施: Ceftazidime-avibactam (Drug)
Ceftazidime-Avibactam plus metronidazole
Experimental
干预措施: metronidazole (Drug)
Meropenem
Active Comparator
干预措施: Meropenem (Drug)
结局指标
主要结局
The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set.
时间窗: At the test of cure visit (Day 28 to35)
The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.
次要结局
- The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set.(At late follow up (LFU) visits (Day 42 to 49))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the end of treatment (EOT) (within 24 hours after last IV dose))
- The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the late follow up (LFU) (Day 42 to 49))
- The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry.(while on study therapy (from Day 1 to Day 14))
- Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality.(study duration (from screening to Day 49 LFU visit))
- Safety and Tolerability by Incidence: Extent of Exposure.(study duration (from screening to Day 49 LFU visit))
- Safety and Tolerability: Clinical Laboratory Evaluation Hematology.(study duration (from screening to Day 49 LFU visit))
- Safety and Tolerability:ECG , QTcB and QTcF Intervals(EOT visit/any observation on treatment)
- The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set.(At the test of cure (TOC) (Day 28 to 35))
- The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry.(while on study therapy (from Day 1 to Day 14))
- Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry.(study duration (from screening to Day 49 LFU visit))
- Plasma Concentrations for Ceftazidime and Avibactam(At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug.)
研究者
研究点 (1)
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