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

NCT00234949 | Completed Phase 4

• 1 other identifier: M04-699
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate

Secondary Outcomes (3)

• Adverse event rates

• Bacteriologic cure rates

• Patient reported outcomes

Interventions

cefdinir DRUG

cephalexin DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

MeSH Terms

Conditions

Cellulitis

Interventions

Cefdinir; Cephalexin

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Global Medical Information

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: October 10, 2005
• Study Start: March 1, 2005
• Last Updated: October 25, 2007

Record last verified: 2007-10