رادار التجارب AI | ||
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حالة التجربة السريرية NCT07236814 لـ الإنفلونزا هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
جامعة العاصمة الطبيةSuraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting المرحلة الثالثة ٣٨٤ عشوائية
Suraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting
- Sur-Ose-Hospital-Prophylaxis
suraxavir marboxil
oseltamivir
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةOseltamivir Arm All subjects will be randomized to receive suraxavir marboxil placebo (40mg on the first day) and oseltamivir (75mg each day during the first five days). | Oseltamivir Oseltamivir (75mg each day during the first five days) Suraxavir marboxil placebo Suraxavir marboxil placebo (40mg on the first day). |
تجريبيةsuraxavir marboxil All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil (40mg on the first day). | Suraxavir marboxil Suraxavir marboxil (40mg on the first day) Oseltamivir Oseltamivir (75mg each day during the first five days) |
مقارن بالدواء الوهميControl Arm All subjects will be randomized to receive oseltamivir placebo(75mg each day during the first five days) and suraxavir marboxil placebo (40mg on the first day). | Oseltamivir Placebo Oseltamivir placebo(75mg each day during the first five days) Suraxavir marboxil placebo Suraxavir marboxil placebo (40mg on the first day). |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
The proportion of room contacts who develop clinical influenza within 5 days, with a virus subtype consistent with that of the index case. | The proportion of room contacts who develop clinical influenza\* within 5 days, with a virus subtype consistent with that of the index case.
\*Clinical influenza is defined as a positive influenza virus detection by Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT), accompanied by at least one respiratory symptom (fever or chills, muscle or joint pain, headache, fatigue) and at least onesystemic symptom (cough, nasal congestion, sore throat). | within 5 days |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
The proportion of room contacts who develop clinical influenza (as defined above) within 10 days | The proportion of room contacts who develop clinical influenza (as defined above) within 10 days, with a virus subtype consistent with that of the index case. | within 10 days |
The proportion of room contacts with laboratory-confirmed influenza within 5 days | The proportion of room contacts with laboratory-confirmed influenza (defined as a positive influenza virus RAT or NAAT result, regardless of symptoms) within 5 days, with a virus subtype consistent with that of the index case. | Within 5 days |
The incidence of post-treatment changes in the influenza virus sequence | Among room contacts who become infected with influenza virus within 10 days, the incidence of post-treatment changes in the influenza virus sequence (based on viral sequence analysis). This includes the incidence of events such as the I38T amino acid substitution, the H275Y amino acid substitution, and other emerging amino acid substitutions in the PA and NA sequences. | Within 10 days |
(1)Inclusion Criteria for Index Cases:
① Patients hospitalized at a participating medical institution.
The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.
Age ≥ 2 years.
Positive for influenza virus as determined by a Rapid Antigen Test (RAT) or Nucleic Acid Amplification Test (NAAT) on a respiratory specimen (e.g., oropharyngeal swab, nasopharyngeal swab, sputum, or bronchoalveolar lavage fluid).
(2) Inclusion Criteria for Room Contacts:
① Patients hospitalized at a participating medical institution.
The subject and/or their legal guardian agrees to participate in this clinical study, has signed the informed consent form, and is able to comply with the protocol requirements for follow-up and complete all study procedures and assessments.
③ Age ≥ 12 years.
Expected to remain hospitalized for ≥ 72 hours.
Shares a room with at least one hospitalized index case who has been confirmed with influenza virus infection by RAT or NAAT on a respiratory specimen within the last 120 hours and developed influenza-related symptoms within the last 120 hours, and is expected to share the same room for ≥ 24 hours.
⑥ Negative for influenza virus as determined by a Nucleic Acid Amplification Test (NAAT) on a throat swab collected on Day 1.
(1) Index Cases There are no exclusion criteria for index cases. (2) Exclusion Criteria for Room Contacts:
* Room contacts with a known allergy to the active ingredients or excipients of the investigational drugs.
Room contacts who have been diagnosed with or have had an influenza virus infection in the past 12 weeks.
Use of any anti-influenza antiviral drugs within 2 weeks prior to screening, including: neuraminidase inhibitors, polymerase inhibitors, hemagglutinin inhibitors, and M2 ion channel blockers (e.g., Oseltamivir, Zanamivir, Peramivir, Favipiravir, Arbidol, Baloxavir Marboxil, Amantadine, or Rimantadine, or other anti-influenza drugs approved by the NMPA).
Known to be pregnant or breastfeeding. (Subjects who suspect they may be pregnant must report this to the investigator, who will confirm with a pregnancy test).
History of fever (axillary temperature ≥ 37.3°C) within 72 hours prior to screening.
- Child-Pugh class B or C, or an eGFR ≤ 60 mL·min-¹·(1.73 m²)-¹. ⑦ Any subject deemed unsuitable for participation in the study by the investigator.
جامعة العاصمة الطبية157 تجارب سريرية نشطة للاستكشافBeijing Municipality