A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Cefdinir; Cephalexin; Cephalosporins

Criteria

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