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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00234949
First received: September 13, 2005
Last updated: October 23, 2007
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Mild to Moderate Uncomplicated Skin and Skin Structure Infections
Drug: cefdinir
Drug: cephalexin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Clinical cure rate

Secondary Outcome Measures:
  • Adverse event rates
  • Bacteriologic cure rates
  • Patient reported outcomes

Estimated Enrollment: 380
Study Start Date: March 2005
  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234949

Sponsors and Collaborators
Abbott
Investigators
Study Director: Global Medical Information Abbott
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234949     History of Changes
Other Study ID Numbers: M04-699
Study First Received: September 13, 2005
Last Updated: October 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Cefdinir
Cephalexin
Skin Infection

Additional relevant MeSH terms:
Skin Diseases, Infectious
Infection
Skin Diseases
Cephalexin
Cefdinir
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014