EUCTR2004-000365-35-ES进行中（未招募）1 期
Prospective, Open-label, Non-comparative, Multicenter Study for the Secondary Prophylaxis of Invasive Fungal Infections (IFI) with Voriconazole in Patients with Allogeneic Stem Cell Transplants
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer S.A
- 入组人数
- 75
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
- •Male and female patients with the diagonosis of acute leukemia or acute transformation of chronic myeloic leukemia and with allogenic stem cell transplantation (myeloablative or non-myeloablative regimen), planned in the next 3 weeks and previous proven or probable IFI in the last 6 months, defined according to the MSG/EORTC diagnostic criteria (Ascioglu et al., CID 2002) at the time of the initial diagnosis of IFI, and with no signs or symptoms of active disease.
- •Signed and dated informed consent will be obtained
- •Females of childbearing potential must have a negative serum B-HCG pregnancy test and be practicing an effective form of contraception
- •Age >= 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant or lactating women, or women of childbearing potential not
- •using an acceptable method of contraception
- •Severe disease other than underlying condition, likely to jeopardize the
- •planned termination of the study (e.g. acute myocardial infarction,
- •unstable angina pectoris)
- •Abnormal baseline findings considered by the investigator to be
- •indicative of conditions that might affect study results (e.g. short bowel
- •Previous history of zygomycosis (eg Mucor, Absidia, Rhizopus)
- •Positive serum galactomannan antigen test (level 1.5)
- •Active, symptomatic, uncontrolled IFI (persistence of clinical
- •symptoms related to active fungal disease)
- •Any biological fungal criterion of active fungal disease as defined by
- •the MSG-EORTC criteria, i.e. persistence of positive microbiological
- •blood cultures or Aspergillus antigenemia, at time of randomization
- •(Appendix E)
- •Patients with candiduria
- •Previous failure of voriconazole in the treatment of IFI
- •Known intolerance to azole compounds
- •Concomitant use of sirolimus, ergot alkaloids, terfenadine, astemizole,
- •cisapride, pimozide, quinidine, carbamazepine, rifampicin,
- •phenobarbital, ritonavir or efavirenz which might interfere with the
- •evaluation of study drugs during the study specific systemic diseases
- •Other medical conditions, including HIV-positive serology, that would
- •interfere with the evaluation of the therapeutic response or safety of the
- •Alcohol and/or any other drug abuse
- •Previous participation in this trial
- •Abnormal laboratory test results, defined as impaired hepatic function,
- •as shown by but not limited to (transaminases, alkaline phosphatases,
- •or bilirubin > 5 x Upper Limit of Normal [ULN])
- •Impaired renal function, as shown by but not limited to estimated
- •creatinine clearance (Clcr) < 50 mL/minute (as per Cockroft-Gault
- •formula (Appendix F)
- •Any other condition which, in the investigator's judgment, might
- •increase the risk to the subject or decrease the chance of obtaining
- •satisfactory data to achieve the objectives of the study
- •Mental condition rendering the subject unable to understand the nature,
- •scope and possible consequences of the study and/or evidence of an
- •uncooperative attitude
- •Unable and/or unlikely to comprehend and/or follow the protocol
- •Participation in any other studies involving investigational or marketed
- •products, concomitantly or within 30 days prior to entry in the study
- •Anticipated survival less than 72 hours
研究者
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