Pharmacokinetics of Antistaphylococcal Antibiotics in Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 10
- 主要终点
- Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin
研究概览
简要总结
Multiple center, open-label, PK study
详细描述
Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in hospitalized infants with suspected systemic infection or receiving one of the study drugs per local standard of care. Number of participants are 16-32 evaluable per each study drug of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Days 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sufficient intravascular access
- •Suspected systemic infection or receiving 1 of the study drugs per standard of care
- •informed consent from legal guardian
排除标准
- •history of allergic reaction to study drugs
- •urine output <0.5 mL/hr/kg over the prior 24 hours
- •serum creatinine >1.7 mg/dl
- •Any condition in investigator judgment precludes participation because it could affect participant safety
研究组 & 干预措施
Ticarcillin-clavulanate antibiotic
Cohort Gestational Age (GA) Postnatal Age (PNA) Dose
- <30 weeks <14 days: 75 mg/kg Q12 hrs x 6 doses
- <30 weeks ≥14 days-45 days 75 mg/kg Q 8 hours x 6 doses
- <30 weeks >45 days-90 days 75 mg/kg Q 6 hours x 6 doses
Brand name is Timentin. This drug is an antibiotic used to treat a wide variety of bacterial infections. It is a combination of two drugs & both treat bacterial infections. Ticarcillin is a penicillin-type antibiotic that stops bacterial growth & clavulanate potassium is an enzyme inhibitor that helps the ticarcillin work better.
干预措施: Antibiotic (Drug)
Rifampin generic antibiotic
Cohort GA PNA Dose
- <32 weeks <14 days 10 mg/kg Q 24 hours x 4 doses
- <32 weeks ≥14 days-120 days 15 mg/kg Q 24 hours x 4 doses
- ≥32 weeks <14 days 15 mg/kg Q 24 hours x 4 doses
- ≥32 weeks ≥14 days-120 days 20 mg/kg Q 24 hours x 4 doses
The brand name is Rifadin, Rimatane. This drug is an antibiotic and a first line antituberculotic and unlabeled use for infections caused by staphylococcus aureus & staphylococcus epidermis.
干预措施: Antibiotic (Drug)
Clindamycin Generic Antibiotic
Cohort GA PNA Dose
- <30 weeks <14 days 10 mg/kg Q 12 hours x 6 doses
- <30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses
- <30 weeks >45 days-120 days 10 mg/kg Q 6 hours x 6 doses
The brand name is Cleocin. This drug is an antibiotic used to treat a wide variety of bacterial infections and serious infections.
干预措施: Antibiotic (Drug)
结局指标
主要结局
Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin
时间窗: 72 hours
Pharmacometric analysis of area under the curve at steady state for cohort 1 participants who were dosed with rifampin 10mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
Cohort 1: Maximum concentration (Cmax) of rifampin
时间窗: 72 hours
Pharmacometric analysis of maximum concentration after first dose for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
Cohort 1: Clearance (CL) of rifampin
时间窗: 72 hours
Pharmacometric analysis of the clearance for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
Cohort 1: Volume of distribution at steady state (Vss) of rifampin
时间窗: 72 hours
Pharmacometric analysis of volume of distribution at steady state for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA \< 32 weeks, PNA \< 14 days)
次要结局
- Cohort 1: Adverse events for participants receiving rifampin(7 days after last study dose)
- Cohort 1 participants: serious adverse events for participants receiving rifampin(7 days after last study dose)
研究者
Phillip Brian Smith
Principal Investigator
Duke University