EUCTR2011-002955-33-RO进行中（未招募）不适用
Clinical and microbiological assessment of prulifloxacin in patients with Acute Bacterial Rhinosinusitis (ABRS) - Prulifloxacin in ABRS
Aziende Chimiche Riunite Angelini Francesco S.p.A0 个研究点开始时间: 2014年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Male or female adults (age > 18 years) with no limitation of race using an appropriate birth control method.
- •2. Patients with Acute Bacterial Rhinosinusitis (ABRS) defined as a superinfection of a pre-existing Acute Viral Rhinosinusitis characterized by persistent symptoms for 10 days or an increase of symptoms after 5 days, and with a duration lower than 12 weeks
- •3. Clinical diagnosis of ABRS defined as the presence of two (including at least one between nasal blockage/congestion/obstruction or nasal discharge) or more of the following signs and symptoms
- •- nasal blockage/congestion/obstruction,
- •- nasal discharge: anterior/post nasal drip,
- •- facial pain/pressure,
- •- reduction/loss of smell.
- •4.Clinical diagnosis of moderate/severe ABRS
- •5.Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent prior to the inclusion in the study.
- •Are the trial subjects under 18? no
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.Known hypersensitivity or allergy to prulifloxacin or other fluoroquinolone antibacterials and/or to any component of the prulifloxacin tablet.
- •2. Known hypersensitivity or allergy to substances used for topical or intravenous anesthesia/sedation (only for patients requiring anesthesia/sedation related to diagnostic procedures)
- •3. Nosocomial sinus infection or infections following or associated with naso-tracheal intubation.
- •4. Chronic rhinosinusitis (duration of symptoms for more than 12 weeks) or complicated rhinosinusitis (brain abscess or venous trombosis).
- •5. Nasal polyps. The absence of nasal polyps should be endoscopically confirmed.
- •6. Patients with nasal anatomic abnormalities (i.e., septum deviation) that not allowed or impaired the middle meatus visualization and/or sampling.
- •7. History of sinus surgery.
- •8. History of tendinopathy associated with use of fluoroquinolones.
- •9. Childbearing potential where pregnancy is not excluded by pregnancy test in urine (ß-HCG), or lactation.
- •10. Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase, or with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •11. Known severe liver and/or renal insufficiency (AST, ALT, ?-GT and/or creatinine levels more than twice as high as the Upper Laboratory Norm).
- •12.Immunosuppressed patients or patients with cystic fibrosis.
- •13. Concurrent infections and/or neoplasm.
- •14. Concomitant treatment with hypoglycemic drugs.
- •15. Concomitant treatment with xanthines.
- •16. Treatment with antibiotics or antibacterials within the previous week.
- •17. Treatment with experimental drugs in the previous 4 weeks.
- •18. Positive history for drugs and alcohol abuse. Patients who had an alcohol or drugs abuse within 24 h before the enrollment in the present study will be also excluded.
- •19. Inability to comply with the protocol requirements, instructions and study-related restrictions (i.e., uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study).
- •20. Vulnerable subjects (i.e., persons kept in detention).
- •21. The patient is the Investigator or his/her deputies, first grade relatives, assistant, pharmacist, or other personnel directly involved in the study conduct.
- •22. Participation to an interventional clinical trial within 3 months prior to the Screening visit prior to the inclusion in the study.
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