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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00234949

Collaborator

(none)

380

Enrollment

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

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

Study Start Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

Clinical cure rate []

Secondary Outcome Measures

Adverse event rates []
Bacteriologic cure rates []
Patient reported outcomes []

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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