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

Phase 3

Active, not recruiting

• Conditions: Uncomplicated Skin and Soft Tissue Infections

• Registration Number: CTRI/2015/01/005361
• Lead Sponsor: Sun Pharmaceutical Industires Ltd

Brief Summary

This will be a randomized, double-blind, double-dummy, comparative, active-controlled, parallel-group multicentric study of 10 days treatment duration followed by a *’Test of Cure’* visit (7-14 days post therapy) with an objective to compare the efficacy, safety and tolerability of FDC of Cephalexin Extended Release (375 mg) anc Clavulante Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infections.

The study will be conducted at 15-17 centres spread over the different geographical locations of India. Adequate number of subjects will be enrolled in equal proportion to have 148 evaluable subjects.The priamry objective of the study is to compare the efficacy of FDC of Cephalexin Extended Release (375 mg) anc Clavulante Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets with respect to clincial outcome (Clinical Cure, clinical improvement or clnical failure) at *’Test of Cure’* visit (7-14 days post therapy) in patients aged 12 to 75 years (both inclusive) with uncomplicated skin and soft tissue infections. The secondary objective of the study are to compare the safety and tolerability of FDC of Cephalexin Extended Release (375 mg) anc Clavulante Potassium (125 mg) Tablets with Cephalexin Extended Release (375 mg) Tablets in the Treatment of Uncomplicated Skin and Soft Tissue Infections.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-15
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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.
• 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.
• 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.
• Note: 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.

Exclusion Criteria

• 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.
• Subjects requiring hospitalization or parenteral antibiotic treatment.
• 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).
• 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).
• Subjects with concomitant condition requiring non-study antibacterial therapy.
• Subjects with involvement of perianal area, facial cellulitis or cellulitisassociated with animal or human bite (except insect bite).
• Subjects with skin and soft tissue infection with suspected or proven contiguous bone, nail bed or scalp involvement.
• Subjects on chronic immunosuppressive therapy, including use of high dose corticosteroids (≥40 mg prednisolone daily or equivalent), or history of acquired immunodeficiency syndrome (AIDS).
• 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 subject’s ability to participate in the study.
• 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.
• Subjects unwilling or unable to comply with the study procedures.
• Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcome	Test of cure visit (7-14 days after end of treatment)

Secondary Outcome Measures

Name	Time	Method
Microbiological Outcome	Test of cure visit (7-14 days after end of treatment)

Trial Locations

Locations (17)

Aster Aadhar Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Bhatia Hospital Medical Research Society; 🇮🇳 Mumbai, MAHARASHTRA, India

Down Town Hospital, G S Road,; 🇮🇳 Kamrup, ASSAM, India

Gandhi Hospital Musheerabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Institute of Post-Graduate Medical Education and Research (IPGMER); 🇮🇳 Kolkata, WEST BENGAL, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Kle Society’s Hospital And Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Marwari Hospital & Research Centre, SJ Road, Athgaon,; 🇮🇳 Kamrup, ASSAM, India

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

MV Hospital and Research Center; 🇮🇳 Lucknow, UTTAR PRADESH, India

Scroll for more (7 remaining)

Aster Aadhar Hospital

🇮🇳Kolhapur, MAHARASHTRA, India

Dr Snehal Sachin Patil

Principal investigator

drsnehal.aacr@gmail.com