Official Title: “A Comparative Study of the Safety, Tolerability, and Efficacy of Cefdinir and Cephalexin for the Treatment of Subjects With Mild to Moderate Uncomplicated Skin and Skin Structure 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: cefdinir
• Drug: cephalexin

Primary Measures

• Clinical cure rate

Secondary Measures

• Adverse event rates
• Bacteriologic cure rates
• Patient reported outcomes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Global Medical Information Study Director Abbott  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00234949

Study ID Number: M04-699

ClinicalTrials.gov Identifier: NCT00234949

Health Authority: United States: Food and Drug Administration