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临床试验/NCT01456234
NCT01456234终止4 期

Comparison of Time From Symptom Onset to Oseltamivir Access When Oseltamivir is Prescribed by Pharmacists vs. Physicians and the Impact on Symptoms, Oseltamivir Resistance, and Patient Safety

Trial Management Group Inc.15 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
48
试验地点
15
主要终点
Time from symptom onset to Oseltamivir access

研究概览

简要总结

The main purpose of this study is to see if patients with the flu would receive oseltamivir treatment more quickly if it were prescribed by a pharmacist as compared to a physician, and to see if there is any difference in the effect of treatment on flu symptoms and overall health. Another reason for doing the study is to see how accurately pharmacists can diagnose the flu as compared to physicians. Viruses that are exposed to antiviral medications (like oseltamivir) sometimes develop a resistance to the medication. This means that the medication is no longer as effective in treating the symptoms caused by the virus. The development of viral resistance to oseltamivir will also be followed in this study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patients with Oseltamivir Prescription

Active Comparator

Patients arriving at the pharmacy with a prescription for Oseltamivir

干预措施: Oseltamivir (Drug)

Patients with signs, symptoms of flu

Experimental

Patients arriving at the pharmacy with signs, symptoms of flu that the pharmacist diagnoses as having flu and being suitable for pharmacist prescribing of Oseltamivir according to an algorithm.

干预措施: Oseltamivir (Drug)

结局指标

主要结局

Time from symptom onset to Oseltamivir access

时间窗: Confirmed at Visit 1, Day 1

次要结局

  • Positive Predictive Value (PPV) of Influenza Clinical Diagnosis(Confirmed at Visit 1, Day 1)
  • Oseltamivir Resistance(Confirmed at Visit 1, Day 1 and Visit 2, Day 5)
  • Influenza Signs and Symptoms(Collected from Day 1 to Day 5)
  • Adverse Events(Collected over 21 days)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (15)

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