EUCTR2006-005196-17-GB进行中（未招募）1 期
A phase II, Multicenter, Randomised, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute Influenza
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
入选标准
- •1. Age =18 years
- •2. 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. However , this requirement is waived if subject has a history of fever in the 24 hours prior to screening and has administered antipyretic(s) in the 6 hours before screening.
- •3. Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of any severity (mild, moderate, or severe)
- •4. Presence of at least one constitutional symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) of any severity (mild, moderate, or severe)
- •5. Onset of illness no more than 48 hours before presentation. Note: Time of onset of illness is defined as either (1) the time when the temperature (either oral or rectal) was first measured as elevated (at least one ºC of elevation-oral temperature), OR (2) the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
- •6. Rapid Antigen Test (RAT) performed on an adequate specimen collected from the anterior nose (bilateral) and posterior pharynx (swab) is positive. A negative initial RAT may be repeated within one hour of obtaining a negative result. A second negative RAT result will exclude the subject from evaluation for enrollment.
- •7. Females of childbearing potential must report one of the following:
- •- Be surgically sterile
- •- Have been sexually abstinent 4 weeks prior to date of screening evaluation and be willing to remain abstinent through 4 weeks after study drug administration
- •- Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches and have been using these for 3 months prior through 4 weeks after study drug administration
- •- Use an intra-uterine device (IUD), or adequate barrier contraception (or double-barrier method such as condom or diaphragm with spermicidal gel or foam) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
- •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 breast-feeding
- •2. History of chronic obstructive pulmonary disease or other chronic respiratory disease requiring daily pharmacotherapy
- •3. History of chronic renal impairment requiring hemodialysis or known or suspected to have moderate or severe renal impairment (actual or estimated creatinine clearance <50 mL/min)
- •4. History of congestive heart failure requiring daily pharmacotherapy with symptoms consistent with New York Heart Association Class II, III, or IV within the past 12 months
- •5. Immunocompromised status due to illness or previous organ transplant
- •6. Current use of systemic immunosuppressive medications or treatments
- •7. Use of rimantadine, amantadine, zanamivir, or oseltamivir in the past 7 days
- •8. Immunized against influenza with live attenuated virus vaccine (FluMist®) in the previous 21 days
- •9. Clinical evidence of active bacterial infection at any body site requiring therapy with oral or systemic antibiotics
- •10. Clinically significant signs of acute respiratory distress
- •11. Clinically significant signs of acute cardiac disease
- •12. Screening ECG which suggests acute or chronic ischemia and/or medically significant dysrhythmia
- •13. Presence of a chronic disease or illness(es) with either clinical or historical evidence of recent exacerbation of such disease(s) or illness(es) or lack of control of such disease(s) or illness(es)
- •14. History of hepatitis B, hepatitis C, or human immunodeficiency virus infection
- •15. History of alcohol abuse or drug addiction within 1 year prior to admission in the study
- •16. Participation in a study of any investigational drug within the last 30 days
- •17. Positive urine pregnancy test
研究者
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