CTRI/2011/12/002193已完成2 期
AN OPEN LABEL DOSE RANGING, EFFICACY, SAFETY AND TOLERABILITY PHASE IIA STUDY OF TOPICAL RECOMBINANT LYSOSTAPHIN GEL FORMULATION IN SUBJECTS WITH UNCOMPLICATED STAPHYLOCOCCUS AUREUS SKIN AND SKIN STRUCTURE INFECTIONS RECOMBINANT LYSOSTAPHIN GEL FORMULATION IN SUBJECTS WITH UNCOMPLICATED STAPHYLOCOCCUS AUREUS SKIN AND SKIN STRUCTURE INFECTIONS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
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
入选标准
- •1Subjects 18 years and above, of either sex
- •2Informed consent given in written form
- •3Should have a confirmed uncomplicated Staphylococcus aureus skin and skin structure (wounds, burns, ulcer, abscess, etc) infection of not less than 2 cm2 and no more than 60 cm2 area over assessable and evaluable site of body.
- •4.Signs and symptoms consistent with infection (pain out of proportion to clinical findings, tenderness on palpation, swelling, erythema, indurations and pus formation -at least three of these should be present.
- •5.All subjects regardless of the disease type should have appropriate cultures obtained with Staphylococcus aureus isolate and susceptible to lysostaphin.
- •6.Women of child bearing age must have a negative urine pregnancy test and should agree to use effective contraceptive measures during study.
- •7.Post operative uncomplicated surgical wound
排除标准
- •Exclusion Criteria:
- •1.Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •2.Alcohol dependence, alcohol abuse or drug abuse within past one year.
- •3.Moderate to heavy smoking (10 cigarettes/day)
- •4.Clinically significant illness within 4 weeks before the start of the study
- •5.Asthma, urticaria or other allergic type reactions after taking any medication.
- •6.Subject with diabetes.
- •7.Positive HIV, Hepatitis B & C tests.
- •8.Any history of hypersensitivity to study drugs
- •9.Subjects with necrotizing mastitis, gas gangrene and osteomyelitisSite of infection other than skin like bacteramia, endocardites and meningitis.
- •10.Subject treated with previous antibiotics (systemic or topical) with Staphylococcus aureus activity for 24 hours and treatment extending in to 72 hours prior to first dose of study drug. Unless documented to be a treatment failure (72 hours of treatment and not responding)
- •11.Prior isolation of Staphylococcus aureus with resistance to lysostaphin.
- •12.Infections that have high cure rate after surgical incision alone should not be Included in the study.
- •13.Subject who has participated in any other clinical trial or bioequivalence study involving drug administration and collection of blood samples or has donated blood in the preceding 12 weeks period of the study.
- •Subjects who have:
- •1.Systolic blood pressure less than 90 mm of Hg and more than 150 mm of Hg
- •2.Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (1-3 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.
- •3.Pulse rate below 50/minute and above 105/minute
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