PER-034-09已完成未知
A PROSPECTIVE, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY & EFFICACY OF ANIDULAFUNGIN WHEN USED TO TREAT CHILDREN WITH INVASIVE CANDIDIASIS, INCLUDING CANDIDEMIA
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Diagnosis of CIC from a blood culture or a culture of a sample from a normally sterile site obtained within 96 hours prior to entering the study.
- •Subjects of both sexes from 1 month to <18 years of age. Patients of childbearing age should use appropriate contraceptive methods, as directed by the researcher, throughout the trial.
- •For each subject, their parents or legal guardian must be willing and able to give informed consent in writing signed and dated. The consent of the child or adolescent will be obtained when appropriate. It will be obtained before recruitment.
- •Will be available throughout the study and can withstand the restrictions of the study.
排除标准
- •Premature infants born before 36 weeks of gestation (unless the sum of the gestational age plus the chronological age is at least 44 weeks).
- •Known history of hypersensitivity allergy or severe reaction to echinocandins.
- •Girls who are pregnant or breastfeeding, or who expect to become pregnant during the study,
- •Subjects who have received more than 4.8.hom? Of systemic antifungal treatment for Candida infection considering their inclusion in the study.
- •Subjects who have not responded to antifungal treatment with any systemic antifungal for this episode of candidiasis / candidemia. Recurrence in the following two weeks is considered a failure of previous treatment.
- •Subjects presenting any of the following anomalies in analytical parameters: Total bilirubin, AST or ALT> 5 times greater than the upper limit of normal
- •Subjects that require continuation of treatment with another systemic antifungal (non-absorbable oral azoles will be allowed [such as clotrimazole]). Exception: the first six subjects recruited between 1 month and <2 years of age may receive a second systemic antifungal at the discretion of the investigator.
- •Subjects with poor venous access that would prevent intravenous administration of a drug or the collection of several blood samples.
- •Patients who have participated in a study of a drug or device under investigation (without indications approved by the FDA and the EMEA) in the four weeks prior to the study. Experimental use of approved drugs is allowed if the subject has received a stable pattern for four weeks before entering the study and is expected to maintain that stable pattern throughout the study.
- •Life expectancy <72 hours;
- •Subjects with suspected osteomyelitis, endocarditis or candidiasic meningitis.
- •Subjects who have prostheses in a suspected infection site will be excluded, unless the device is removed at the entrance to the study. (Hemodialysis shunts [AV fistulas] may remain in place.
- •Subjects with a heart valve prosthesis or vascular graft that are suspected to be the focus of Candida infection and positive blood cultures.
- •Any other serious, acute or chronic medical or psychiatric disorder, electrocardiogram abnormalities (ECG) or any laboratory abnormality that may increase the risk associated with participation in the study or administration of the product under investigation or interfere with the interpretation of the results of the study and, in the opinion of the researcher, prevent participation in this study.
研究者
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