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

Phase 4

Completed

• Conditions: Mild to Moderate Uncomplicated Skin and Skin Structure Infections

• Registration Number: NCT00234949
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-23
• Last Update Posted: 2007-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical cure rate

Secondary Outcome Measures

Name	Time	Method
Adverse event rates
Bacteriologic cure rates
Patient reported outcomes