ISRCTN76443564已完成未知
The efficacy and safety evaluation of ceftriaxone and sulbactam combination (1.5 gram) in patients with skin and soft tissue infections: an open label, parallel, randomized, prospective comparative trial
Ranbaxy Laboratories Ltd (India)0 个研究点目标入组 400 人开始时间: 2007年6月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 400
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. Male and female patients aged >18 years
- •2. Diagnosis of skin and skin structure infections of sufficient severity and with signs of systemic illness requiring injectable antibiotics. The diagnosis of Skin and Soft Tissue Infections (SSTI) should be made on the basis of clinical and microbiological criteria as follows:
- •a. Infection that involves soft tissue (including deep and extensive cellulitis; abscesses, necrotizing fasciitis, surgical site infections; burns [<10% of total body surface area]) or
- •b. Requiring surgical interventions or
- •c. Associated with significant underlying disease/s such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy or venous insufficiency.
- •A surgical intervention is not necessary for entering this study, but it will be allowed at the start of the study.
- •3. At least two of the following signs and symptoms:
- •3.1. Drainage or discharge
- •3.2. Fever (oral temperature >38.50 °C or 101.40 °F)
- •3.3. Erythema
- •3.4. Swelling / fluctuation
- •3.5. Local warmth
- •3.6. Pain / tenderness
- •3.7. White Blood Cell (WBC) count of >10.0000 cells / mm3
- •4. Patients of SSTI requiring parenteral antibiotic administration for minimum of 5 days
- •5. All patient should have a microbiological specimen (culture material) obtained from skin lesions prior initiation of therapy
排除标准
- •1. Unwilling or unable to give informed consent
- •2. Female patients of childbearing potential who are not practicing a reliable form of contraception
- •3. Significant mental retardation
- •4. Less than 18 years old
- •5. Hypersensitivity to ceftriaxone, sulbactam or any other beta-lactam agents
- •6. Presenting with sustained shock (Systolic Blood Pressure (SBP) <90 mm Hg for 2 hours, despite adequate fluid resuscitation)
- •7. Concomitant infection that requires treatment with another antimicrobial agent
- •8. Pseudomonas aeruginosa as a baseline isolate
- •9. Severely impaired arterial blood supply and insufficiency (absence of arterial pulse) such that the likelihood of amputation of the infected anatomical site is within one month
- •10. Presence of hepatic disease, acute hepatic failure or acute decompensation of chronic hepatic failure
- •11. Abnormal laboratory values at admission to study:
- •11.1. Serum Glutamic-Oxaloacetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT) >45 IU
- •11.2. Alkaline phosphate or serum bilirubin >2 mg/dl
- •11.3. Hemoglobin <9 g/dl, WBC<1000 /mm3
- •11.4. Platelet count < 75000 /mm3
- •12. Impaired renal function (serum creatinine >1.5 ml/min) or those requiring peritoneal dialysis or hemodialysis
- •13. Use of other antimicrobial drugs after wound specimen for culture has been obtained. Prior anti-infective use, (<3 days of oral antibiotics and <1 day any injectable antibiotics) even up to the day of patient enrollment, would be acceptable if a culture is obtained showing the persistence of pathogen.
- •14. Clinical laboratory determinations outside of an acceptable range should be excluded unless the finding can be attributed to current drug(s) therapy
- •15. Patients requiring further surgical intervention that might influence the evaluation of response to study medication
- •16. Any other underlying conditions compromising the ability to respond to a bacterial infection. e.g. AIDS, corticosteroid, chemotherapy, immunocompromised.
- •17. Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed
- •18. Any patient not reasonably expected to complete the trial
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