ISRCTN14790675已完成4 期
An open, randomized comparative study of the efficacy and safety of using Ecomed (powder for oral suspension, containing azithromycin 100mg/5ml and lactulose 200mg/5ml, manufactured by JSC AVVA RUS, Russia) compared with Sumamed (powder for suspension, containing azithromycin 100mg/5ml, by Pliva Hrvatska doo, Croatia) in children with rhinosinusitis.
OJSC AVVA RUS0 个研究点目标入组 100 人开始时间: 2019年2月22日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Outpatient patients of both sexes from 3 to 14 years.
- •2. Established diagnosis of Acute Purulent Sinusitis - evaluation of complaints, anamnesis, temperature, R-picture and rhinoscopy data - pus in the middle nasal passage and/or in the nasopharynx dome.
- •3. Ability to regularly receive the studied drugs and perform research procedures.
- •4. The Form of the Written Informed Consent to participate in the study is signed by one of the parents or the legal representative of the patient.
- •5. Informing the patients' parents that during the entire study period the patient should not take prebiotics, probiotics, synbiotics, sorbents.
排除标准
- •1. Intolerance to azalides, macrolides and other components of the drug.
- •2. Administration of antibacterial drugs, including sulfonamides, within 28 days before the start of screening.
- •3. Complicated course of infectious diseases of the upper and lower respiratory tract.
- •4. Bacterial infection of another location, requiring the administration of antibiotics.
- •5. Oncological disease without remission, at least for 5 years before the start of the study.
- •6. Epilepsy, febrile convulsions in history.
- •7. Impaired immunity according to anamnesis.
- •8. Immunodeficiency.
- •9. Active neoplastic process.
- •10. Any other serious illness or condition that could jeopardize patient safety, affect life expectancy, or hinder successful treatment or monitoring of a patient according to the protocol.
- •11. The reluctance of the child or his legal representatives to participate in clinical research.
- •12. Drug use, alcoholism, mental illness of the legal representative of the patient.
- •13. Participation in other clinical studies of medical drugs less than 3 months before the start of the study.
研究者
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