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

NCT ID: NCT00234949

Last Updated: 2007-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31

Brief 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.

Conditions

Mild to Moderate Uncomplicated Skin and Skin Structure Infections

Keywords

Cefdinir; Cephalexin; Skin Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

cefdinir

Intervention Type: DRUG

cephalexin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Principal Investigators

Global Medical Information

Role: STUDY_DIRECTOR

Abbott

Other Identifiers

M04-699

Identifier Type: -

Identifier Source: org_study_id