EUCTR2006-002473-47-CZ进行中（未招募）不适用
A double blind, randomized, placebo controlled, multi-center trial of oseltamivir for the seasonal prophylaxis of influenza in immunocompromised patients
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 470
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
- •Age greater than or equal to 1 year
- •Negative rapid diagnostic test for influenza at baseline
- •Immunocompromised subject defined as documented:
- •SOT (liver, kidney or both) recipient OR
- •Allogenic HSCT
- •Parent/guardian willing and able to comply with study requirements and give consent (country specific age cut off).
- •Subject able to comply with study requirements and willing to give assent (for minors, country specific age cut off), as appropriate
- •For adult subjects, willing and able to comprehend and give written informed consent
- •Subjects, in the reproductive age group, must agree to utilize an effective method of contraception throughout the study period and for one reproductive cycle following cessation of study therapy
- •Females of childbearing potential must have a negative urine pregnancy test prior to start of study medication
- •° Receiving ongoing immunosupression OR in the investigator´s opinion, not immune reconstituted.
- •Are the trial subjects under 18? yes
- •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
- •Symptoms suggestive of influenza-like illness including but not limited to fever, cough, or nasal congestion
- •Subjects with fever (temperature > or = 37.8 deg Celsius)
- •Influenza vaccination in the 4 weeks prior to randomization
- •Positive rapid diagnostic test for influenza
- •SOT within 6 months of the time of randomization
- •SOT other than liver, kidney or liver and kidney
- •Have in the investigator’s opinion experienced acute rejection in the 4 weeks prior to randomization
- •HSCT patients with no evidence of engraftment (engraftment is defined as the point at which a patient can maintain a sustained absolute neutrophil count (ANC) of > 500/mm3 and sustained platelet count of > or = 20,000/mm3, lasting > or = 3 consecutive days without transfusions)
- •HSCT subjects not discharged from hospital after their initial hospitalization for transplantation
- •Have evidence of veno-occlusive disease, acute or chronic extensive graft versus host disease
- •Currently or previously (in the six months prior to randomization) administered lymphocyte depleting monoclonal antibodies (example: antithymocyte globulin, antilymphocyte globulin) for management of transplant
- •Have other co-morbid conditions that could affect patient survival or graft function including but not limited to a post-transplant lymphoproliferative disease (PTLD), autoimmune disease including inflammatory bowel disease and psoriasis, untreated thyroid disease, and significant active infection
- •Estimated creatinine clearance < 10 ml/min in adults or < 10 ml/min/1.73 M2 in children (Cockroft-Gault equation for adults and the Schwartz equation in children)
- •Patients currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis or hemofiltration
- •Have evidence of active or uncontrolled opportunistic infections (bacterial, fungal, or viral - including cytomegalovirus [CMV] or polyoma virus [BKV]) at the time of randomization. Patients with HCV or HBV are not excluded.
- •Patients with known HIV infection
- •Patients who are being evaluated or treated for an active malignancy at the time of randomization excluding malignancies for which the SOT or HSCT may have been performed.
- •Uncontrolled vascular, neurologic, or pulmonary disease. Uncontrolled is defined as disease requiring change of therapy or hospitalization in the 4 weeks preceding randomization. Change of therapy is defined as dose increase or change of medication.
- •Patients with severe diarrhea or other gastrointestinal disorders which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
- •Allergy to the test medication
- •Hereditary fructose intolerance (for subjects who will e taking the liquid formulation)
- •Antiviral treatment (example: amantadine, rimantadine, zanamavir, oseltamivir and ribavirin) for influenza in the 2 weeks prior to randomization
- •Patients taking probenecid medication
- •Patients who are pregnant or breast-feeding
- •Participation in a clinical trial or an expanded access trial with an investigational drug in the 4 weeks prior to randomization or concomitantly with this study .
研究者
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