EUCTR2015-001225-16-Outside-EU/EEA进行中（未招募）不适用
An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Subjects 6 to 17 Years of age, Inclusive, With Cystic Fibrosis
Johnson & Johnson Pharmaceutical Research & Development L.L.C0 个研究点目标入组 22 人开始时间: 2015年4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
- 22
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
- •- Boy or girl between 6 years of age and 17 years of age, inclusive, with a confirmed diagnosis of CF (documented sweat chloride =60 mEq/L by quantitative pilocarpine iontophoresis test [QPIT] and/or homozygosity for ?F508 genetic mutation (or heterozygosity for 2 known mutations)
- •- Subjects must be medically stable, without acute decline in physical condition in the investigator's judgment.
- •- A parent or the subject's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) and capable of providing it, as described in Section 11.2.3, Informed Consent/Assent and as approved by institutional-specific guidelines
- •- Suspected or diagnosed with an infection, colonization, or prophylaxis for which the subject is receiving antibiotic therapy
- •- Menarchal girls must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, or abstinence for the duration of the study) before entry and throughout the study
- •- Menarchal girls, must have a negative urine pregnancy test at screening
- •- If a boy, must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., abstinence, vasectomy, double-barrier, partner using effective contraception)
- •- Be a non-smoker
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 22
- •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
- •- History of colonization with B. cepacia within the past 6 months
- •- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator. If the results of the chemistry, hematology, or urinalysis tests are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. (Goss 2006) This determination must be recorded in the subject’s source documents and initialed by the investigator
- •- Clinically significant abnormal physical examination or vital signs at screening as deemed appropriate by the investigator. If the results of the physical examination or vital signs, are outside normal reference ranges for a subject’s age, even if considered to be clinically significant, the subject can be included if, in the investigator's judgment, the abnormalities are consistent with the subject's underlying disease(s) or therapies. (Goss 2006) This determination must be recorded in the subject’s source documents and initialed by the investigator
- •- History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other ß-lactam antibiotics
- •- Known allergy to heparin or history of heparin induced thrombocytopenia, if an indwelling cannula (e.g., heparin lock) or central line is used
- •- Subjects concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration
- •- Subjects concomitantly treated with probenecid or VPA (refer to Section 5.5, Concomitant Therapy)
- •- Had substantial loss of blood (more than 10% of total blood volume) within 3 months before the administration of study drug
- •- Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug’s half-life, whichever is longer, before the administration of the study drug is scheduled
- •- If a menarchal girl, pregnant, breast-feeding or planning to become pregnant during the study
- •- Preplanned surgery or procedures that would interfere with the conduct of the study
- •- Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- •- History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or subject’s verbal report
研究者
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