EUCTR2010-021422-35-DE进行中（未招募）不适用
Efficacy, safety and tolerability of Influcid tablets in patients (1 to 65 years old) suffering from upper respiratory tract infections with flu-like symptoms.A randomized, international, multicenter, controlled clinical trial. - INFI (Influcid in Feverish Infections)
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
- 520
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. Males and females aged from 1 to 65 years;
- •2. Diagnosed URTI with presence of the following symptoms for equal or less than for 24 hours:
- •a) Fever (axillary temperature = 37.5°C) and
- •b) At least one upper respiratory tract symptom: either
- •i) one nasal symptom (plugged nose, runny nose, sneezing) or
- •ii) one pharyngeal symptom (scratchy throat, sore throat, pharynx hyperemia) or
- •iii) cough (ordinary cough without suspicion of acute lower respiratory tract disease) and
- •c) at least one general symptom: either
- •i) feeling tired or
- •ii) weakness or
- •iii) body aches or
- •iv) for children only: irritable / whiny or less active.
- •3. Written informed consent according to the applicable law;
- •4. Willingness and ability to comply with all procedures of the trial.
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting any of the following criteria will not be included in the study:
- •1. Severe or complicated course of the URTI (e.g. shortness of breath, dyspnoea, tachypnea, hypoxia, central nervous system (CNS) findings, severe dehydration, renal failure, multi-organ failure, septic shock, musculoskeletal (rhabdomyolysis) and cardiac (myocarditis) complications);
- •2. Signs of acute lower respiratory tract disease (e.g. bronchiolitis, bronchitis, pneumonia);
- •3. Current symptoms mainly induced by other acute ENT (Ear-Nose-Throat) disease such as tonsillitis, sinusitis, otitis media;
- •4. Any present chronic inflammatory ENT and respiratory tract disease (e.g. allergic rhinitis, bronchitis, bronchial asthma, obstructive pulmonary disease (COPD), cystic fibrosis and adenoidal hypertrophy);
- •5. Obstructive anatomic lesions in the nasopharynx such as nasal polyps, tumours or severe septal deviations;
- •6. Patients with severe heart diseases, HIV-infection, unstable diabetes mellitus, coeliac disease and/or immunosuppression and only for adolescents-adults tuberculosis as well as lues at any stage;
- •7. Patients with severe renal or hepatic dysfunction at any time during the past 12 months prior to enrolment into the trial;
- •8. Children with congenital anomalies of heart, kidney or liver;
- •9. Any significant alarm symptom within the past 6 months prior to enrolment into the trial, e.g. unintentional weight loss, or any other sign indicating serious or malignant disease;
- •10. Evidence of any malignant disease during the past 5 years prior to enrolment into the trial;
- •11. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption;
- •12. Hypersensitivity to any of the ingredients and/or excipients of Influcid;
- •13. Hypersensitivity to any of the ingredients and/or excipients as well as any known contraindications to the symptomatic treatment defined in this protocol;
- •14. Positive rapid test for group A ß-hemolytic streptococci (GABHS);
- •15. Treatment with antibiotics, glucocorticosteroids, immunomodulators (including drugs contraining probiotics), or antihistamines during the past 4 weeks prior to or at enrolment into the trial as well as current indication requiring these drugs during the trial;
- •16. Indication for administration of or treatment with antiviral drugs (e.g. oseltamivir);
- •17. Treatment with any antipyretics, nasal decongestants, expectorants and/or any other cold medication or measure for relief of URTI e.g. local anesthetics, anti-inflammatory drugs, antitussiva, homeopathic drugs, nutritional supplements or drugs containing zinc, echinacea, garlic or vitamin C (³ 100 mg per day), during the past 7 days prior to or at enrolment into the trial;
- •18. Heavy smoking or known or suspected drug addiction incl. alcohol abuse;
- •19. Women of childbearing potential without adequate contraception or women, who want to become pregnant, are pregnant or breast-feeding;
- •20. Participation in another clinical trial during the past 3 months prior to enrolment into the trial;
- •21. For patients = 18 years: Incompetence or incapability of understanding nature, meaning and consequences of the trial;
- •For patients < 18 years: Irresponsible parents or their legal representatives unable to understand nature, meaning and consequences of the trial.
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