EUCTR2009-015864-32-LV进行中（未招募）不适用
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Meropenem in Hospitalized Children With Complicated Intra-Abdominal Infections
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium0 个研究点目标入组 140 人开始时间: 2010年11月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1 - Subject randomly assigned to treatment postoperatively or intra-operatively after visual confirmation of established cIAI (presence of pus within the abdominal cavity) including the following eligible diagnoses:
- •– appendicitis complicated by rupture and/or abscess
- •– traumatic perforation of the intestines, which are being operated on more than 12 hours after perforation occurred
- •– acute gastric, duodenal, or gall bladder perforations, which are being operated on more than 24 hours after perforation occurred
- •– secondary peritonitis due to perforated viscus, postoperative or other focus of infection. (Subjects with inflammatory bowel disease or ischemic bowel disease are eligible to enroll provided there is bowel perforation)
- •– intra-abdominal bacterial abscess (including liver)
- •Subject randomly assigned to treatment pre-operatively and has pre-operative clinical evidence of cIAI including all of the following:
- •– Evidence of systemic inflammatory response as demonstrated by at least one of the following:
- •? Fever (oral temperature >38.0C, tympanic temperature >38.3C, or rectal or core temperature >38.8C) or hypothermia (rectal or core temperature <35.0C)
- •? Have leukocytosis (WBC count =15,000 cells/µL OR =15% immature neutrophils , regardless of the total peripheral white cell count)
- •? Hypotension defined by the following:
- •o For children greater than 1 year of age: Systolic blood pressure =70 mm Hg + (2 multiplied by age [in years])
- •o For children aged 3 months to =1 year: Systolic blood pressure =70 mm Hg
- •– At least one of the following physical signs consistent with cIAI:
- •o Abdominal pain or tenderness
- •o Localized or diffused abdominal wall rigidity
- •o Presence of abdominal mass
- •– Supportive radiologic findings in the abdomen such as intraperitoneal abscess detected on computer tomography scan films or an ultrasound;
- •2 - Must have a requirement for surgical intervention (eg, laparotomy, laparoscopic surgery, or percutaneous drainage) to manage the cIAI within the 24 hours before to within the 24 hours after randomization;
- •3 - Must, based on the judgment of the investigator, require hospitalization initially and antibacterial therapy for 5 to 14 days in addition to surgical intervention for the treatment of the current cIAI. (Note that the subject must require at least 3 days of IV antibiotic therapy initially).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 140
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1 - Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other ß-lactam antibiotics. Note: Subjects with a history of mild non urticarial skin rash temporally related to but considered not associated with the previous use of ß-lactam antibiotics are permitted to enroll in the study. For such subjects, there must be a description of the rash and documentation by the investigator that upon review of the history it is his/her opinion that the rash was unlikely due to any of the above-mentioned classes of drugs for the subject to qualify for inclusion in the study;
- •2 - Concomitant infection including but not limited to suspected or confirmed meningitis or other CNS infection requiring systemic antibiotic or antifungal therapy at the time of randomization. (Clarification: possible bacteremia with a presumed intra abdominal pathogen is acceptable);
- •3 - Have received more than 24 hours of systemic antibiotic therapy immediately preceding the start of the infusion of the first dose of IV study drug therapy
- •4 - Girls who are pregnant or are nursing a child or are menarchal, and if sexually active are not practicing a highly effective method of birth control (eg, prescription hormonal contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream or gel, male partner sterilization) as local regulations permit, before screening and do not agree to continue using a highly effective method of birth control (as previously described) for 30 days after administration of the last dose of study drug therapy. Note: for all menarchal girls, confirm a negative urine or serum pregnancy test (ß-human chorionic gonadotropin [ß-hCG]) at screening, before enrolling the subject into the study;
- •5 - Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6 months before randomization.
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