EUCTR2014-003485-24-Outside-EU/EEA进行中（未招募）不适用
A Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis - CXA-PEDS-13-08
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •To be eligible for enrollment, a patient must fulfill all of the following inclusion criteria:
- •1. Provide written parental (or appropriate legal representative) informed consent and age appropriate assent prior to any study-related procedure not part of normal medical care;
- •2. Male or female from birth (defined as at least 7 days postnatal) to <18 years of age;
- •3. Able to comply with the protocol for the duration of the study;
- •4. For female patients who have undergone menarche:
- •Is not pregnant (as confirmed by the serum pregnancy test at Screening) and not planning to become pregnant within 30 days of last study drug administration,
- •Is non-lactating, AND
- •Is abstinent OR utilizes one of the following for at least 1 month prior to screening: hormonal contraceptives (injectable, oral, patch, or vaginal ring),
- •intrauterine device (IUD), or barrier method (diaphragm). This method must be used in combination with a barrier method of contraception for their male partner
- •(condom). Patients must be willing to practice these methods for at least 30 days after study drug administration;
- •5. For male patients who are sexually active with female partners who have undergone menarche: patient must be using and willing to continue using medically acceptable forms
- •of contraception (abstinence, or male condom for patients plus an additional method of contraception for their female partners) from Screening and for at least 30 days after study drug administration;
- •6. Receiving standard of care intravenous antibiotic therapy for suspected or diagnosed Gram-negative infection or for peri-operative prophylaxis; and
- •7. Have a calculated creatinine clearance rate (CLCR) = 80 ml/min/1.73m2 as determined by the Schwartz (2009) equation at baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •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
- •To be eligible for enrollment, a patient must not meet any of the following exclusion criteria:
- •1. Known allergy/hypersensitivity to any ß-lactam antibacterial;
- •2. History of clinically significant renal, hepatic, or hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure in the 24-hour window prior to enrollment);
- •3. Planned use of cardiopulmonary bypass or dialysis;
- •4. Planned blood transfusion within 24 hours of study drug administration;
- •5. Clinically significant abnormal laboratory test results not related to the underlying infection, as determined by Investigator;
- •6. Height or weight outside of the 5th to 95th percentile;
- •7. Receipt of piperacillin/tazobactam within 24 hours of study drug administration;
- •8. Use of any medications known to inhibit tubular secretion of renally-excreted drugs;
- •9. Known use of illicit drugs or abuse of alcohol or cigarettes;
- •10. Patients likely to be at risk of hemodynamic disturbance (as determined by Investigator) following collection of the required PK blood samples;
- •11. Use of any investigational drug or participation in any experimental procedure in the 30 days preceding study entry.
研究者
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