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临床试验/EUCTR2010-021621-12-BE
EUCTR2010-021621-12-BE进行中（未招募）不适用

AI114373: A Phase III international, randomized, double-blind, double-dummy study to evaluate the efficacy and safety of 300 mg or 600 mg of intravenous zanamivir twice daily compared to 75 mg of oral oseltamivir twice daily in the treatment of hospitalized adults and adolescents with influenza. - N/A

GlaxoSmithKline Research & Development Ltd0 个研究点目标入组 600 人开始时间: 2011年1月19日最近更新:
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适应症
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
600
研究概览入排标准研究者记录与标识符相似试验

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

  • •Subjects eligible for enrolment in the study must meet all of the following criteria:
  • •1.Male or female aged = 16 years; (= 18 years where required by local regulatory authorities or IRB/IECs); a female is eligible to enter and participate in the study if she is:
  • •a.of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
  • •b.of child-bearing potential, has a negative pregnancy test at Baseline, and agrees to one of the following methods for avoidance of pregnancy during the study and until the Post-Treatment +28 Days Follow-up Assessment:
  • •Abstinence; or,
  • •Oral contraceptive, either combined or progestogen alone; or,
  • •Injectable progestogen; or,
  • •Implants of levonorgestrel; or,
  • •Estrogenic vaginal ring; or,
  • •Percutaneous contraceptive patches; or
  • •Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS Product Label; or,
  • •Has a male partner who is sterilized; or,
  • •Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository).
  • •2. Vital signs criteria at Baseline defined as:
  • •- Presence of fever [oral temperature of =38°C (=100.4°F), rectal/core, tympanic of =38.5°C (=101.3°F), or axilla =37.4°C (=99.3°F)] at Baseline. However, this requirement is waived if:
  • •i. The subject has a history of fever within the 24 hours prior to Baseline, with or without administration of antipyretic(s) or,
  • •ii. The subject has no history of documented fever as defined above, but reports a symptom of feverishness at some time during the 48 hours prior to Baseline.
  • •AND at least 2 out of the following 4:
  • •- Oxygen saturation <95% on room air by trans-cutaneous method, or need for any supplemental oxygenation or ventilatory support [mechanical ventilation, bi-level positive airway pressure (bipap), continuous positive airway pressure (cpap)], or increase in oxygen supplementation requirement of =2 litres for subjects with chronic oxygen dependency. For those subjects with a history of chronic hypoxia (without supplemental oxygen), an oxygen saturation of at least 3% below the patient’s historical baseline oxygen saturation will satisfy this criterion.
  • •- Respiration rate >24 breaths per minute. For those subjects who require ventilatory support or oxygen supplementation, this requirement is waived.
  • •- Heart rate >100 beats per minute.
  • •- Systolic blood pressure <90 mmHg.
  • •3.Onset of influenza symptoms within 6 days prior to study enrolment. Symptoms may include cough, dyspnea, sore throat, feverishness, myalgias, headache, nasal symptoms (rhinorrhea, congestion), fatigue, diarrhea, anorexia, nausea and vomiting.
  • •4. Clinical symptoms of influenza with positive influenza diagnostic test result.
  • •- Subjects who have confirmed influenza as determined by a positive result in a rapid antigen test (RAT) for influenza A or influenza B, or a laboratory test for influenza including but not limited to influenza virus antigen test, virus culture or RT-PCR test.
  • •Strong suspicion of influenza illness based on clinical symptoms and local
  • •surveillance information.
  • •- Subjects with a negative RAT or pending other influenza laboratory test may be enrolled.
  • •5. Subjects willing and able to give written informed consent to participate in the study and to adhere to the

排除标准

  • •Subjects meeting any of the following criteria must not be enrolled in the study:
  • •1. Subjects who have taken more than a total of 3 days (6 doses) of approved antiinfluenza therapy (i.e. oral oseltamivir, oral inhaled zanamivir, oral amantadine, oral rimantadine, oral ribavirin, or IV peramivir, where approved) in the period from onset of symptoms and prior to enrolment.
  • •2.Subjects who, in the opinion of the investigator, are not likely to survive beyond 48 hours from Baseline.
  • •3.Subjects who are considered to require concurrent therapy with another influenza antiviral medication.
  • •4.Subjects who are known or suspected to be hypersensitive to any component of the study medications.
  • •5.Subjects with creatinine clearance =10 mL/min who are not being treated with continuous renal replacement therapy (CRRT).
  • •6.Subjects who require Extra Corporeal Membrane Oxygenation (ECMO) at Baseline (enrolled subject who subsequently require ECMO may continue in the study).
  • •7.Subjects who require routine/intermittent hemodialysis or continuous peritoneal dialysis (due to inability to provide appropriate dosing schedule for oseltamivir) at Baseline. CRRT modalities are allowed (CVVH, CVVHD, CVVHDF, SLED, SCUF, CAVH, CAVHD, CAVHDF).
  • •8.Liver toxicity criteria based on local laboratory results obtained within 24 hours of Baseline:
  • •ALT or AST =3xULN and bilirubin =2xULN
  • •ALT =5xULN
  • •9. Underlying chronic liver disease with evidence of severe liver impairment.
  • •10.History of severe cardiac disease or clinically significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator, will interfere with the safety of the individual subject.
  • •11.Females who are pregnant (positive urine or serum pregnancy test at Baseline) or are breastfeeding.
  • •12.Treatment with investigational parenteral anti-influenza drugs (IV peramivir, IV zanamivir or IV oseltamivir) in the 4 weeks prior to Baseline.
  • •13. Exclusion criterion #13 removed in Protocol Amendment 02.
  • •14. French and Korean subjects: the French or Korean subject has participated in any study using an investigational drug during the previous 30 days. This criterion may also apply in other countries if required by local regulatory authorities or IRB/IECs.

研究者

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