CTRI/2015/01/005361
进行中（未招募）
3 期
Comparative Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release (375 mg) and Clavulanate Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infection
Sun Pharmaceutical Industires Ltd0 个研究点目标入组 180 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: null- Uncomplicated Skin and Soft Tissue Infections
- 发起方
- Sun Pharmaceutical Industires Ltd
- 入组人数
- 180
- 状态
- 进行中（未招募）
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Subjects of either sex, aged 12 to 75 years (both inclusive) who have given written informed consent/assent including audio visual recording of consent procedure to participate in the study. An additional written informed consent will be obtained from parent/legally acceptable representative (as applicable) in case assent is taken from subjects aged \<18 years.
- •2\. Subjects with diagnosis of uncomplicated skin and soft tissue infections (uSSTI) and culturable microbiological specimen, with an onset of infection \<\= 7 days requiring antibiotic therapy. Acceptable clinical diagnoses of uSSTIs include: simple abscess, impetigo, furunculosis, carbuncles, cellulitis (area \<10 cm2\), erysipelas, folliculitis, paronychia, superficial wound infections (traumatic, post\-surgical) etc.
- •Note: Microbiological specimens shall be obtained by aspiration of anabscess or swabbing of a draining lesion, prior to the initiation of therapy.
- •3\. Subjects with at least three or more of the following local signs and symptoms of uSSTI accompanied with or without systemic features of infection such as pain/tenderness, purulent drainage/discharge, erythema with or without induration, swelling, fluctuance, heat/localized warmth, regional lymph node swelling or tenderness and/or extension of redness.
- •Microbiological specimens (i.e. pus aspirate, swabs from the site of infection) will be collected from all subjects at the time of screening for culture and antibacterial susceptibility testing as per the Hospital/Clinic protocol or practice. Subjects with resistant isolate(s) to study medication or those who are found to be culture negative showing clinical improvement to study drug will be allowed to continue in the study at the discretion of the investigator. Subjects with persistence or worsening of signs and symptoms or appearance of new signs and symptoms associated with skin lesions after at least six doses of treatment will be withdrawn from the study and considered as treatment failures. Their further treatment will be at the discretion of the investigator. The investigator may withdraw a subject at any time during the course of the study if the same is in the best interest of the subject.
- •Acceptable causative pathogens for uSSTI include: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Klebsiella pneumoniae, Proteus mirabilis, Escherichia coli, Moraxella (Branhamella) catarrhalis and Haemophilus influenzae
排除标准
- •1\. Subjects with history of hypersensitivity to cephalexin, other cephalosporins, penicillins or other beta\-lactam class of antibiotics, clavulanate potassium or any of the excipients of study formulation.
- •excipients\-Microcrystalline cellulose, Sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, hypromellose, hydroxypropyl cellulose, Talc, PEG 400, titanium dioxide, indigo Carmine and colloidal anhydrous silica.
- •2\. Subjects requiring hospitalization or parenteral antibiotic treatment.
- •3\. Subjects with complicated acute bacterial skin and skin structure infections (ABSSSI) as judged by the investigator or with chronic or underlying skin condition at the site of infection (e.g., a secondarily infected atopic dermatitis, eczema, acne vulgaris or burn wounds ) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic instruments).
- •4\. Subjects who have received antibiotic treatment for \>\= 24 hours during the 72 hours period prior to enrollment in the study (unless treatment failure was documented).
- •5\. Subjects with concomitant condition requiring non\-study antibacterial therapy.
- •6\. Subjects with involvement of perianal area, facial cellulitis or cellulitisassociated with animal or human bite (except insect bite).
- •7\. Subjects with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement.
- •8\. Subjects on chronic immunosuppressive therapy, including use of high dose corticosteroids (\>\=40 mg prednisolone daily or equivalent), or history of acquired immunodeficiency syndrome (AIDS).
- •9\. Subjects with a history of clinically significant diseases (such as uncontrolled metabolic disorders, cancer etc.) or disorders (other than the disease in consideration) that in the opinion of the investigator may (i) put the subject at risk because of participation in the study (ii) interfere with the study evaluations or (iii) cause concern regarding subjectâ??s ability to participate in the study.
结局指标
主要结局
未指定
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