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

October 23, 2007 updated by: Abbott

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

380

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical cure rate

Secondary Outcome Measures

Outcome Measure
Patient reported outcomes
Adverse event rates
Bacteriologic cure rates

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Global Medical Information, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Estimate)

October 25, 2007

Last Update Submitted That Met QC Criteria

October 23, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-699

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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