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.

Phase 3

Completed

• Conditions: Uncomplicated skin and soft tissue infection

• Registration Number: CTRI/2010/091/001153
• Lead Sponsor: Ranbaxy Laboratories Ltd

Brief Summary

This study is an open-label, non-comparative study with an objective to compare the Efficacy, Safety and Tolerability of Fixed Dose Combination of Cephalexin Extended Release and Clavulanate Potassium Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infections. The study is to be conducted at 10 centres all over India. The primary outcome is Investigator assessed clinical outcome in clinically evaluable subjects at test-of-cure visit (7-9 days after end of treatment) and secondary outcome is Microbiological outcome in all microbiologically evaluable subjects at test-of-cure visit (7-9 days after end of treatment).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-30
• Last Update Posted: 2013-03-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.
• Subjects of either sex, aged more then or equal to 12 years and weighing more then or equal to 40 kg.
• 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).
• 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.

Exclusion Criteria

• 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 formulation2.
• Subjects requiring hospitalization or parenteral antibiotic treatment3.
• 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 medication5.
• Subject with a complicated skin and soft tissue infection as judged by the investigator6.
• 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 vulgaris8.
• 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 disease9.
• Subjects with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement10.
• 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 participation11.
• 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 screening12.
• Subjects with a history of drug or alcohol abuse13.
• Subjects unwilling or unable to comply with the study procedures14.
• Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study15.
• 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 subjects	At test-of-cure visit (7-9 days after end of treatment)

Secondary Outcome Measures

Name	Time	Method
Microbiological outcome in all microbiologically evaluable subjects	At test-of-cure visit (7-9 days after end of treatment)

Trial Locations

Locations (10)

Aarthi Skin Care Clinic; 🇮🇳 Chennai, TAMIL NADU, India

Amar Medical and Research Center; 🇮🇳 Jaipur, RAJASTHAN, India

Government Medical College & Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Khobragade Hosp; 🇮🇳 Nagpur, MAHARASHTRA, India

Medical college & SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

Medical college and SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

New Civil Hospital; 🇮🇳 Surat, GUJARAT, India

Renova Skin & Laser Clinic; 🇮🇳 Jaipur, RAJASTHAN, India

SF-068, 1st Floor Galleria Complex; 🇮🇳 Gurgaon, HARYANA, India

Tagore Hospital and Research Center; 🇮🇳 Jaipur, RAJASTHAN, India

Aarthi Skin Care Clinic

🇮🇳Chennai, TAMIL NADU, India

Dr. L. Aarthi

Principal investigator

044-42872295

draarthi_derm@hotmail.com