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.
Minimum age: 13 Years.
Maximum age: N/A.
- 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:
- Localized warmth
- Purulent drainage/discharge
- Regional lymph node swelling or tenderness
- Extension of redness
- Acceptable USSSI include, but are not limited to:
- Simple abscess
- Wound infection
- A sample for microbiologic culture must be obtained from the primary infection site
within 48 hours prior to study drug administration.
- 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
- 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
- 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