Mild to Moderate Uncomplicated Skin and Skin Structure Infections Clinical Trial
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
| NCT number | NCT00234949 |
| Other study ID # | M04-699 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | September 13, 2005 |
| Last updated | October 23, 2007 |
| Start date | March 2005 |
| Verified date | October 2007 |
| Source | Abbott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 380 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 13 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Abbott |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Clinical cure rate | |||
| Secondary | Adverse event rates | |||
| Secondary | Bacteriologic cure rates | |||
| Secondary | Patient reported outcomes |