EUCTR2007-002527-32-ES进行中（未招募）1 期
A Phase III, Multicenter, Ramdomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute InfluenzaEstudio de fase III, doble ciego, multicéntrico, aleatorizado y controlado con placebo para evaluar la seguridad y la eficacia de Peramivir Intramuscular en sujetos con gripe aguda no complicada - The IMPROVE 2 Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 625
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
- •1. Male and non-pregnant female subjects age =18 years
- •2. A Rapid Antigen Test (RAT) performed on an adequate specimen collected from an anterior nasal swab. A negative initial RAT may be repeated within one hour of obtaining a negative result.
- •3. Presence of fever at time of screening of =38.0 ºC (=100.4 ºF) taken orally, or =38.5 ºC (=101.2 ºF) taken rectally. For subjects with a positive RAT at the time of screening, a subject self-report of a history of fever or feverishness within the 24 hours prior to screening will also qualify for enrollment in the absence of documented fever at time of screening. For subjects with no positive RAT at screening, fever as defined above must be documented at time of screening
- •4. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
- •5. Presence of at least one constitutional symptom (myalgia [muscle aches], headache, feverishness, or fatigue) of any severity (mild, moderate, or severe)
- •6. Onset of symptoms no more than 48 hours before presentation for screening
- •7. Written informed consent
- •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
- •1. Women who are pregnant or breast-feeding
- •2. Presence of clinically significant signs of acute respiratory distress
- •3. History of severe chronic obstructive pulmonary disease (COPD) or severe persistent asthma
- •4. History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class IV functional status within the past 12 months
- •5. History of chronic renal impairment requiring hemodialysis and/or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min)
- •6. Current clinical evidence of active bacterial infection at any body site that requires therapy with oral or systemic antibiotics
- •7. Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy
- •8. Current treatment for active viral hepatitis C
- •9. Presence of known HIV infection with a CD4 count <350 cell/mm3
- •10. Current therapy with oral warfarin or other systemic anticoagulant
- •11. Receipt of any doses of rimantadine, amantadine, zanamivir, or oseltamivir in the 7 days prior to screening
- •12. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days
- •13. History of alcohol abuse or drug addiction within 1 year prior to admission in the study
- •14. Participation in a previous study of peramivir as treatment for acute influenza or previous participation in this study
- •15. Participation in a study of any investigational drug within the last 30 days
研究者
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