A clinical trial to study the effects of FDC of Cephalexin Extended Release and Clavulanate Potassium Tablets in patients with uncomplicated skin and soft tissue infections.
- Conditions
- Health Condition 1: null- Uncomplicated skin and soft tissue infection
- Registration Number
- CTRI/2010/091/001153
- Lead Sponsor
- Ranbaxy Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Subjects who have given written informed consent/assent to participate in the study. Additional written informed consent will be taken from parents/LAR (as applicable) in case assent is taken from subjects aged less then 18 yrs.
2. Subjects of either sex, aged more then or equal to 12 years and weighing more then or equal to 40 kg.
3. Subjects with diagnosis of uncomplicated skin and soft tissue infections with an onset of infection less then 7 days, judged to require antibiotic therapy. Acceptable clinical diagnoses of uSSTIs include, but are not limited to: simple abscess, impetigo, furunculosis, cellulitis, carbuncles, erysipelas, folliculitis, paronychia, superficial wound infections (traumatic, post surgical).
4. The uncomplicated skin and soft tissue infection is accompanied by 2 or more of the following local signs and symptoms with or without systemic features of infection: pain/tenderness, swelling, erythema, localized warmth, purulent drainage/discharge, induration, regional lymph node swelling or tenderness
5. Subjects who have positive pre-treatment culture from microbiological specimen obtained from the skin lesions. Culture will be defined as positive if at least one of the following skin pathogens is identified: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Klebsiella pneumoniae, Proteus mirabilis, Escherichia coli
Note:Â
Microbiological specimens (e.g., pus aspirate, swabs etc. from the site of infection) as appropriate will be collected for microbiological analysis from all subjects as per the Hospital/Clinic protocol or practice
Treatment will be initiated before the results of culture are available. However, when these results become available, suitability of the subject for inclusion in the study will be reviewed at visit 2 (Day 3-5). Subjects with sterile culture or negative culture for predefined pathogens will be withdrawn from the study. Subjects showing clinical improvement with isolate(s) resistant to study drug will be allowed to continue in the study at the discretion of the investigator. Subjects who have persistence or worsening of signs and symptoms or appearance of new signs and symptoms associated with skin lesions after 3 days of treatment will be considered as treatment failures and will be withdrawn from the study
Surgical intervention (drainage, incision of the tissue swelling etc.) as appropriate will be done as per the discretion of the investigator
1. Subjects with history of hypersensitivity to cephalexin, other cephalosporins, penicillins or other beta-lactam class of antibiotics, clavulanate potassium or other beta-lactamase inhibitors 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. Subjects with a concomitant infection that needs an additional oral or topical anti-microbial agent or which in the opinion of the investigator could preclude evaluation of response to study medication
5. Subject with a complicated skin and soft tissue infection as judged by the investigator
6. A chronic or underlying skin condition at the site of infection (e.g., a secondarily infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic instruments)
7. Subjects with secondarily infected thermal injury (burns) or acne vulgaris
8. Subjects with solitary furuncle, involvement of perianal area, facial cellulitis or cellulitis associated with animal or human bite (except insect bite), diabetic foot ulcers or decubitus ulcers (bed sores) or significant peripheral vascular disease
9. Subjects with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement
10. Subjects with clinically significant cardiovascular, hematological (including subjects with bleeding diathesis, on anticoagulant therapy or with vitamin K deficiency), renal, hepatic, endocrinal (including subjects with history of diabetes mellitus), 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
11. 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
12. Subjects with a history of drug or alcohol abuse
13. Subjects unwilling or unable to comply with the study procedures
14. Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study
15. Subjects with history of immuno-suppression or on chronic immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome (AIDS).
16. Subjects with SGOT/AST or SGPT/ALT > 3.0 times upper limit of normal (ULN) or alkaline phosphatase or serum bilirubin >2.0 times ULN or serum creatinine >2.0 mg/dL
*Microcrystalline cellulose; sodium starch glycolate; colloidal anhydrous silica; magnesium stearate; hypromellose; hydroxypropyl cellulose; talc; opadry; polyethylene glycol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigator assessed clinical outcome in clinically evaluable subjectsTimepoint: At test-of-cure visit (7-9 days after end of treatment)
- Secondary Outcome Measures
Name Time Method Microbiological outcome in all microbiologically evaluable subjectsTimepoint: At test-of-cure visit (7-9 days after end of treatment)