Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 50
- 主要终点
- Death
研究概览
简要总结
The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections
详细描述
The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.
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
- — 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained from parent(s) or legal guardian(s) (Groups 1-5)
- •≤33 weeks gestation at birth (Groups 1-3, 5)
- •≥34 weeks gestation at birth (Groups 4 and 5)
- •PNA <121 days (Groups 1-5)
- •Sufficient venous access to permit administration of study drug (intravenous [IV]) (Groups 1-5)
- •Presenting physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection within 48 hours prior to randomization/first study drug dose (Groups 1-4)**. Complicated intra-abdominal infections include secondary peritonitis, NEC grade II or higher by Bell's criteria, Hirschsprung's disease with perforation, spontaneous intestinal perforation, meconium ileus with perforation, bowel obstruction with perforation, gastroschisis with necrosis and/or perforation, omphalocele with necrosis and/or perforation, neonatal appendicitis, intestinal pneumatosis or portal venous gas, free peritoneal air on abdominal radiographic examination, or abdominal abscess.
- •Suspected or confirmed infection for which the study drug may provide therapeutic benefit and planned CSF collection per standard of care (Group 5).
- •Exclusion Criteria*
- •History of anaphylaxis in response to study drugs (Groups 1-5)
- •Serum creatinine >2 mg/dL within 48 hours on measurement prior to and closest to randomization /first study drug dose (Groups 1- 5)**
- •Known ALT >250 U/L or AST >500 U/L on measurement closest to the time of randomization or first study drug dose (Groups 1-5)**
- •Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety (Groups 1-5)
- •Do not apply for Group 5 participants receiving drug per standard of care
- •Criteria must be satisfied by randomization (randomized Groups 1-3) or first study drug dose (non-randomized Groups 1-3, Group 4 and Group 5), whichever comes first.
排除标准
- 未提供
研究组 & 干预措施
Group 1 (ampicillin +gentamycin +metronidazole)
Ampicillin and gentamycin and metronidazole
干预措施: ampicillin and metronidazole and gentamicin (Drug)
Group 2 (ampicillin +gentamicin+clindamycin)
ampicillin and gentamicin and clindamycin
干预措施: ampicillin and gentamicin and clindamycin (Drug)
Group 3 (piperacillin-tazobactam and gentamicin)
piperacillin-tazobactam and gentamicin
干预措施: gentamicin and Piperacillin- tazobactam (Drug)
Group 4 (metronidazole)
Per standard of care antibiotics, and Metronidazole
干预措施: standard of care antibiotics and metronidazole (Drug)
Group 5 (metronidazole/clindamycin/piperacillin-tazobactam)
metronidazole, clindamycin, or piperacillin-tazobactam
干预措施: metronidazole, clindamycin, or piperacillin-tazobactam (Drug)
结局指标
主要结局
Death
时间窗: Within 30 days after last dose of study drug, up to 40 days
Number of Participants who experienced Death
次要结局
- Number of Participants With Therapeutic Success at Day 30(30 days after last dose of study drug)
研究者
Michael Cohen-Wolkowiez
Associate Professor
Duke University