Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clearance of ticarcillin-clavulanate
研究概览
简要总结
This study will evaluate the safety, tolerability and PK of ticarcillin-clavulanate in infants <91 days of age with suspected systemic infection.
详细描述
4.3 Procedures by Visit
4.3.1 Pre-Study Drug Administration Procedures (Study Day 0)
The following procedures will be completed prior to the administration of study drug:
- Obtain signed and dated informed consent/HIPAA consent
- Collect demographic data and medical history
- Perform a complete physical examination
- Obtain and record infant weight and medication dosing weight for calculation of appropriate study drug dose if different from actual weight
- Record the following labs if obtained within 72 hours prior to the start of study drug. Use the laboratory values closest to enrollment if there have been multiple tests.
a. Hematology: hematocrit, hemoglobin, white blood cell count with differential, platelet count b. Serum chemistry: glucose, creatinine, blood urea nitrogen, aspartate transaminases (AST), alanine transaminase (ALT), alkaline phosphatase, total and direct bilirubin, sodium, potassium, chloride, calcium, magnesium, total protein, albumin f. Record results of sterile body fluid cultures (blood, urine, CSF, peritoneal fluid) obtained as standard clinical care in the 72 hours prior to study drug administration. Record urine cultures only if obtained by sterile catheterization or suprapubic aspiration g. Document antimicrobials and vasopressors in the 72 hours prior to study drug administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- — 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written permission from parent or legal guardian
- •< 91 days of age
- •< 30 weeks gestation at birth
- •Likely to survive beyond the first 48 hours after enrollment
- •Sufficient intravascular access (either peripheral or central) to receive study drug.
- •AND ONE OF THE FOLLOWING
- •Suspected systemic infection
- •Receiving ticarcillin-clavulanate as part of standard of care
排除标准
- •History of allergic reactions to any penicillin, cephalosporins, or beta-lactamase inhibitors
- •Urine output < 0.5 mL/hr/kg over the prior 24 hours
- •Serum creatinine > 1.7 mg/dL
- •Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study
研究组 & 干预措施
ticarcillin-clavulanate
5 doses of IV ticarcillin-clavulanate infants < 14 days PNA will receive 75 mg/kg Q12 infants ≥ 14 days PNA will receive 75 mg/kg Q8
干预措施: Ticarcillin-clavulanic acid (Drug)
结局指标
主要结局
Clearance of ticarcillin-clavulanate
时间窗: steady state samples will be drawn on day 2-3 of study drug therapy (around dose 4, 5, or 6)
The following PK parameters will be estimated: 1. Systemic clearance 2. Volume of distribution 3. Cmax, Tmax, AUC0-Τ, (at steady state), Ke and t1/2 4. CSF/plasma ticarcillin-clavulanate concentration ratio 5. Urine/plasma ticarcillin-clavulanate concentration ratio
次要结局
- Incidence of adverse events as a measure of safety and tolerability(1st dose to 7 days after the last dose)
研究者
Phillip Brian Smith
Associate Professor of Pediatrics
Duke University