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

Condition(s) targeted: Mild to Moderate Uncomplicated Skin and Skin Structure Infections

Intervention: cefdinir (Drug); cephalexin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Global Medical Information, Study Director, Affiliation: Abbott

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.

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 design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Clinical cure rate

Secondary outcome:

Adverse event rates

Bacteriologic cure rates

Patient reported outcomes

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: March 2005
Last updated: October 23, 2007