Status:
COMPLETED
A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin Infections
Lead Sponsor:
Abbott
Conditions:
Mild to Moderate Uncomplicated Skin and Skin Structure Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00234949
Start Date
March 1 2005
Last Update
October 25 2007
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