EUCTR2006-002468-24-FR进行中（未招募）1 期
A double-blind, randomized, stratified, multi-center trial evaluating conventional and high dose oseltamivir in the treatment of immunocompromised patients with influenza
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Rapid diagnostic test positive for influenza in the 24 hours prior to first dose
- •Immunocompromised subject defined as documented:
- •- SOT (liver, kidney or both) recipient OR
- •- Allogenic HSCT
- •Receiving ongoing immunosuppression, OR, in the investigator’s opinion, not immune reconstituted
- •Symptoms suggestive of influenza like illness including, but not limited to fever, cough, or coryza
- •Less or equal 48 hours between onset of influenza like illness and first dose of study drug
- •Acceptable renal function defined as:
- •- Most recent creatinine clearance in the 6 months prior to randomization is > 30 ml/min in adults and > 30 ml/min /1.73M2 in children. Creatinine clearance estimated from serum creatinine measured when subject is not receiving any renal replacement therapy OR
- •- For patients who have not had a creatinine clearance assessment in the 6 months prior to randomization, baseline creatinine clearance > 10 ml/min in adults and > 10 ml/min /1.73M2 in children OR
- •- For patients whose most recent creatinine clearance in the 6 months prior to randomization is < 30 ml/min in adults and < 30 ml/min /1.73M2 in children, baseline creatinine clearance > 10 ml/min in adults and > 10 ml/min /1.73M2 in children
- •Parent/guardian willing and able to comply with study requirements and give consent. (country specific age cut off)
- •Patient able to comply with study requirements and willing to give assent, as appropriate (country specific age cut off)
- •For adult patients, willing and able to comprehend and give written informed consent
- •Patients, 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
- •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
- •SOT within 6 months of the time of randomization
- •Solid Organ Transplant 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 =20,000/mm3, lasting =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 at the time of randomization
- •Have clinical evidence for hepatic decompensation at the time of randomization (clinical icterus, ascites, hepatic encephalopathy, coagulopathy)
- •Have cirrhosis of the liver at the time of randomization
- •Currently or in the six months prior to randomization using T cell depleting 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
- •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 (other than the malignancy for which the SOT or HSCT may have been performed) at the time of randomization
- •Patients with 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 prior to onset of present influenza like illness.
- •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
- •Patients with hereditary fructose intolerance (for subjects who will be taking the liquid formulation)
- •Influenza vaccination in the 2 weeks prior to randomization
- •Antiviral treatment (example: amantadine, rimantadine, zanamivir 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 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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