International Multicenter Double-blind Placebo-controlled Randomized Parallel Group Clinical Trial of Efficacy of Anaferon for Children in the Treatment of Influenza and Acute Respiratory Viral Infections in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 569
- 试验地点
- 27
- 主要终点
- Average Illness Duration
研究概览
简要总结
The purpose of this study is:
• To obtain additional data on therapeutic efficacy of Anaferon for children in the treatment of influenza and acute respiratory viral infections in children
详细描述
The study will enroll outpatient subjects of both sexes aged 3-12 years with clinical manifestations of influenza/Acute Respiratory Viral Infections (ARVI), including fever
≥ 38.0°С having an appointment with a doctor within the first day after the illness onset.
Тhe physician will collect medical history information, perform an objective examination, record the concomitant therapy, and obtain nasal swab specimens for a rapid diagnostic influenza test. If the swab is positive, the doctor shall obtain swab specimens from the nasal cavity and oropharynx (nasopharyngeal swab) for a subsequent real time reverse transcription-polymerase chain reaction (RT-PCR) to determine the viral load of influenza A and/or B virus. If the swab is negative for influenza the doctor shall collect a nasopharyngeal swab for a subsequent PCR test for other respiratory viruses.
If inclusion criteria are met and exclusion criteria are absent at visit 1 (Day 1), the patient will be enrolled in the trial and randomized into one of the two groups: group 1 patients will take Anaferon for children following a 5-day regimen; group 2 patients will receive Placebo using the Anaferon for children 5-day regimen. The parent/adopter of patient will receive a diary where they should record the child's axillary temperature data in the morning and evening, and score the severity of symptoms.
The subject will be monitored for 14 days (screening, randomization - 1 day, treatment - 5 days, follow-up - 1 day; late-scheduled phone "visit" - day 14).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged 3-12 years inclusively.
- •Diagnosis of influenza/ARVI according to physician's examination: body temperature ≥ 38.0°C at the time of examination + symptom score ≥ 4 (at least 1 systemic symptom ≥2 and 1 nasal/throat/chest symptom ≥2 or several symptoms ≥ 1 score).
- •The first 24 hours from the beginning of manifestations of influenza/ARVI.
- •The possibility to start therapy within 24 hours from the first symptoms of ARVI.
- •Availability of a patient information sheet (Informed Consent form) for parents/adoptive parents for participation in the study signed by one of the parents/adoptive parents.
排除标准
- •Suspected pneumonia, bacterial infection or severe disease requiring antibacterial products (including sulfanilamides) starting from the first day of the disease.
- •Clinical symptoms of severe influenza/ARVI requiring hospitalization.
- •Suspected initial manifestations of the diseases having the symptoms similar to the ones of influenza/ARVI (other infectious diseases, influenza-like syndrome at debut of systemic connective tissue diseases, oncohematological and other diseases).
- •Medical history of primary and secondary immunodeficiencies: а) lymphoid system immunodeficiencies (Т-cell and/or B-cell, immunodeficiencies with predominant antibody deficiency); b) phagocytic deficiencies; c) complement factor deficiency; d) combined immunodeficiencies including AIDS secondary to HIV-infection; toxic, autoimmune, infectious, radiation panleukopenic syndrome; systemic lymphocytopenic syndrome; polyclonal lymphocytic activation syndrome; postsplenectomic syndrome; congenital asplenia; immune complex pathological syndrome associated with infectious, autoimmune and allergic diseases.
- •Medical history of sarcoidosis.
- •Exacerbation or decompensation of chronic diseases affecting ability to participate in the clinical study.
- •Medical history of polyvalent allergy.
- •Allergy/intolerance to any of the components of medications used in the treatment.
- •Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
- •Intake of medicines listed in the section "Prohibited concomitant therapy" within 1 month prior to the inclusion in the study.
- •Drug addiction, alcohol consumption at more than 2 alcohol units per day by the subject's parents/adoptive parents.
- •Mental diseases of the subject, parents/adoptive parents.
- •Subjects whose parents/adoptive parents, according to the investigator's point of view, will not follow the observation requirements during the study or study product dosing regimen.
- •Participation in other clinical studies within 3 months prior to the inclusion in the study.
- •Parent/adoptive parent of the subject is related to the investigator team of medical facility directly involved in the study or is a close relative of the investigator. Close relatives include spouse, parents, children or brothers (sisters) regardless of whether they are biological or adoptive ones.
- •Parent/adoptive parent of the subject is working in OOO "NPF "Materia Medica Holding", i.e. is the company official, temporary contract worker or an appointed official responsible for the study or their close relatives.
研究组 & 干预措施
Anaferon for Children
On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily.
干预措施: Anaferon for Children (Drug)
Placebo
On day 1, five tablets are taken in the first 2 hours (one tablet every 30 min), followed by three more tablets regularly spaced during the rest of the day. From day 2 through 5, one tablet is administered three times daily.
干预措施: Anaferon for Children (Drug)
结局指标
主要结局
Average Illness Duration
时间窗: From the time of randomization until the time of recovery/improvement (days 1-14)
Disease duration is assessed until recovery or significant improvement. Average illness duration is defined as the interval between the start of the trial treatment and the start of the first 24-hour period in which the non-specific symptoms and nasal/ throat/ chest symptoms improve to "absent" or "mild" (Total Symptom Score of severity had decreased to ≤2 points) and body temperature returns to 37.2°C or below. Based on patient diary data.
次要结局
- Number of Intakes of Antipyretics(on days 1-5 of therapy)
- Percentage of Patients With Recovery/Improvement in Health(on days 2, 3, 4 and 5 of the treatment)
- Changes in Body Temperature(baseline and days 2, 3, 4 and 5 of observation treatment)
- Percentage of Patients With Normal Body Temperature (≤37.0ºС)(on days 2, 3, 4 and 5 of observation treatment)
- Percentage of Patients With Exacerbation of the Disease Course(14 days of observation treatment)
- Severity of Clinical Manifestations of Influenza / Acute Respiratory Viral Infection by Total Symptom Score.(on days 2-6 of observation treatment)
- Assessment of the Severity of Influenza Virus / Acute Respiratory Viral Infection Using the "Area Under the Curve" for an Overall Symptom Assessment(on days 1-7 of observation (based on days 1-7 on the patient diary data; on days 1, 3, 5 and 7 of observation - according to physician's objective examination))
- Change in Viral Load During the Treatment and Follow-up Periods(on days 1, 3, 5, 7 of observation treatment)