EUCTR2015-004886-98-Outside-EU/EEA进行中（未招募）1 期
A Randomized, Double-Blind, Double Dummy, Comparative, Multicenter Study to Assess the Safety and Efficacy of Topical Retapamulin Ointment, 1%, versus Oral Linezolid in the Treatment of Secondarily-Infected Traumatic Lesions and Impetigo Due to Methicillin-Resistant Staphylococcus aureus
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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. The subject is aged 2 months or older.
- •2. The subject has a secondarily infected traumatic lesion (SITL) or impetigo (bullous
- •or non-bullous).
- •3. The subject has had a negative urine pregnancy test prior to enrolment (if of
- •childbearing potential).
- •4. The subject has a Total Skin Infection Rating Scale (SIRS) Score of at least 8, which
- •must include a pus/exudate score of at least 3 (see Appendix 1).
- •5. The subject and/or parent/legal guardian is willing and able to comply with the study
- •6. The subject or parent/legal guardian, as applicable, has given written informed, dated
- •consent; and the subject has given written assent, if applicable, to participate in the
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 116
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 256
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1. The subject has demonstrated a previous hypersensitivity reaction to pleuromutilins
- •or any component of the retapamulin ointment, or to oxazolidinones.
- •2. The subject has phenylketonuria (PKU) or known hypersensitivity to aspartame.
- •3. The subject has a secondarily infected animal/human bite, or a puncture wound.
- •4. The subject has an abscess; defined as a localized collection of pus caused by
- •suppuration buried in tissues.
- •5. The subject has a chronic ulcerative lesion that is likely to be polymicrobial and
- •unlikely to have Staphylococcus aureus as the causative agent.
- •6. The subject has an underlying skin disease, such as pre-existing eczematous
- •dermatitis, with clinical evidence of secondary infection.
- •7. The subject has systemic signs and symptoms of infection (e.g., a fever; defined as a
- •rectal temperature greater than 101° F or 38.3° C).
- •8. The subject has a bacterial skin infection which, due to extent, depth or severity, in
- •the opinion of the investigator, cannot be appropriately treated by a topical antibiotic
- •(e.g., extensive cellulitis, furunculosis).
- •9. The subject requires surgical intervention including, but not limited to, incision and
- •drainage, for treatment of the infection prior to enrollment in the study, or is likely to
- •require such intervention during the course of the study. This includes subjects who
- •have infected surgical wounds from an amputation.
- •10. The subject has received a systemic antibacterial or steroid, or has applied any
- •topical therapeutic agent (including glucocorticoid steroids, antibacterials and
- •antifungals) directly to the wound, within 24 hours of entry into the study.
- •11. The subject is currently receiving adrenergic agents (e.g., pseudoephedrine).
- •12. The subject is currently receiving serotonergic agents (i.e., antidepressants).
- •13. The subject has a clinical history of pseudomembranous colitis.
- •14. The subject has known, pre-existing myelosuppression, or a history of
- •myelosuppression with prior linezolid use, or is currently receiving a medication that
- •produces bone marrow suppression.
- •15. The subject has a history of seizures.
- •16. The subject has a history of severe renal failure and is undergoing dialysis.
- •17. The subject has a serious underlying disease that could be imminently lifethreatening.
- •18. The subject is pregnant, breast feeding or planning a pregnancy during the study, or
- •of childbearing potential or less than one year post-menopausal and not using an
- •accepted method of contraception (i.e., surgical sterilization, intra-uterine
- •contraceptive device, oral contraception plus barrier contraception, other hormone
- •delivery systems plus barrier contraception, diaphragm or condom in combination
- •with contraceptive cream, jelly or foam).
- •19. The subject has used an investigational drug within 30 days prior to entering the
- •20. The subject has been previously enrolled in this study
- •21. The subject has fructose intolerance, glucose-galactose malabsorption, or sucraseisomaltase
- •insufficiency.
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