A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections
A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections
The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of
 cephalexin in patients with mild to moderate uncomplicated skin/skin structure infections.
Inclusion Criteria:

 -  Ambulatory male or female subjects > 13 years old.

 -  A female subject must be non-lactating and at no risk for pregnancy.

 -  Diagnosis of USSSI with 2 or more of the following local signs and symptoms:

 -  Pain/tenderness

 -  Swelling

 -  Erythema

 -  Localized warmth

 -  Purulent drainage/discharge

 -  Induration

 -  Regional lymph node swelling or tenderness

 -  Extension of redness

 -  Acceptable USSSI include, but are not limited to:

 -  Cellulitis

 -  Erysipelas

 -  Impetigo

 -  Simple abscess

 -  Wound infection

 -  Furunculosis

 -  Folliculitis

 -  A sample for microbiologic culture must be obtained from the primary infection site
 within 48 hours prior to study drug administration.

 Exclusion Criteria

 -  Medical history of hypersensitivity or allergic reaction to penicillin and/or
 cephalosporin (including cefdinir and cephalexin) antibiotics according to the
 judgment of the Investigator.

 -  Subject with a complicated skin and skin structure infection as judged by the
 investigator.

 -  A chronic or underlying skin condition at the site of infection (e.g., a secondary
 infected atopic dermatitis or eczema) or infections involving prosthetic materials
 (e.g., catheter tunnel infections, orthopedic hardware).

 -  A wound secondary to burn injury or acne vulgaris.

 -  Any infection site that requires:

 -  intraoperative surgical debridement;

 -  excision of infected lesions or body parts.

 -  Infections that can be treated by surgical incision alone according to the judgment of
 the Investigator.

 -  Any other infection that necessitates the use of additional concomitant oral or
 parenteral antibiotic therapy.

 -  Known significant renal or hepatic impairment indicated by:

 -  Serum Creatinine > 2.0 mg/dL (176.8 mol/L)

 -  SGOT (AST) > 3x the upper limit of the reference range

 -  SGPT (ALT) > 3x the upper limit of the reference range

 -  Alkaline Phosphatase > 2x the upper limit of the reference range

 -  Total Bilirubin > 2x the upper limit of the reference range

 -  Underlying condition and/or disease that, according to the judgment of the
 Investigator, would be likely to interfere with completion of the course of study drug
 therapy or follow-up.

 -  The Investigator considers the subject an unsuitable candidate for cefdinir or
 cephalexin administration