CTRI/2010/091/001196已完成3 期
Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release and Clavulanate Potassium Tablets in the Treatment of Upper Respiratory Tract Infections - FDC of Cephalaxein ER and Clavulanate Potassium Tablets in treatment of uRTI
Ranbaxy Research Laboratories0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 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
入选标准
- •Subjects of either sex aged more then or equal to 12 years and weighing more then or equal to 40 kg suffering from upper respiratory tract infection (with onset of infection less then 7 days) with diagnosis of acute pharyngitis and/or tonsillitis. Diagnosis will be made on the basis of clinical and microbiological criteria
- •Clinical criteria
- •Clinical diagnosis will be based on following signs and symptoms: sore and scratchy throat and/or pain on swallowing along with any two of following: Tonsillar and/or pharyngeal exudates, tonsillar and/or pharyngeal erythema, fever [temp. more then or equal to 38C/ & more then or equal to 100.4F (or history of fever treated with antipyretics)], uvular edema, tender cervical adenopathy.
- •Microbiological criteria
- •A positive pre-treatment throat swab culture defined as identification of at least one of the following respiratory pathogens: Streptococcus pyogenes, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella (Branhamella) catarrhalis, Staphylococcus aureus.
- •Note: Treatment will be initiated before the results of throat swab culture are available. However,when these results become available (within 3-5 days of enrollment), suitability of subject for inclusion will be reviewed. Subjects with sterile culture or culture not positive for respiratory pathogens as defined above will be withdrawn from the study. Subjects showing clinical improvement with isolate (s) resistant to study medication will be allowed to continue at the discretion of the investigator. Subjects who have persistence or worsening of signs and symptoms or appearance of new signs and symptoms after 3 days of treatment will be withdrawn from the study
排除标准
- •1.Subjects with history of hypersensitivity to cephalexin, other cephalosporins, penicillins, clavulanate potassium or other betalactam class of antibiotics or any of the excipients* of study formulation
- •2.Subjects requiring hospitalization or parenteral antibiotic treatment
- •3.Subjects who have received antibiotic treatment for >/= 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented)
- •4.Infection of the deep tissues of the upper respiratory tract (e.g. epiglottitis, retropharyngeal or buccal cellulitis or abscess of the retropharynx/ tonsil or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (e.g. sinusitis, otitis media or orbital/periorbital cellulitis)
- •5.Subjects with a concomitant infection that needs an additional anti-microbial agent or which in the opinion of the investigator could preclude evaluation of response to study medication
- •6.Subjects with renal failure who are on hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion
- •7.Subjects who are unable to take oral medication
- •8.Subjects with clinically significant cardiovascular, hematological (including subjects with bleeding diathesis, on anticoagulant therapy or with vitamin K deficiency), renal, hepatic, endocrinal, pulmonary, urogenital, gastrointestinal, progressive neurological illness (including subjects with history of epilepsy) or psychiatric illness or any other medical condition that might put the subject at greater risk during study participation
- •9.Pregnant or breast feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test (UPT) at screening
- •10.Subjects with history of drug or alcohol abuse
- •11.Subjects unwilling or unable to comply with the study procedures
- •12.Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study
- •13.Subjects on chronic immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome (AIDS) or hepatitis
- •14.Subjects with SGOT/AST or SGPT/ALT >3.0 times upper limit of normal (ULN) or alkaline phosphatase >2.0 times ULN or serum bilirubin >1.5 times ULN or TLC <4000/mm3 or creatinine clearance of <30 mL/ min (estimated from serum creatinine using the Cockcroft-Gault formula**)
- •*Microcrystalline cellulose; sodium starch glycolate; colloidal Anhydrous silica; magnesium stearate; hypromellose; hydroxypropyl cellulose; talc; opadry; polyethylene glycol
- •**Creatinine clearance (CLcr) = 140 ? age (years) x weight (kg)
- •72 x serum creatinine (mg/dL)
- •For female subjects: Final value as per above formula should be multiplied by 0.85
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