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

Primary Purpose

Mild to Moderate Uncomplicated Skin and Skin Structure Infections

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
cefdinir
cephalexin
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate Uncomplicated Skin and Skin Structure Infections focused on measuring Cefdinir, Cephalexin, Skin Infection

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Clinical cure rate

    Secondary Outcome Measures

    Adverse event rates
    Bacteriologic cure rates
    Patient reported outcomes

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    October 23, 2007
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00234949
    Brief Title
    A Study to Compare Cefdinir and Cephalexin for the Treatment of Mild to Moderate Uncomplicated Skin 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 Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild to Moderate Uncomplicated Skin and Skin Structure Infections
    Keywords
    Cefdinir, Cephalexin, Skin Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    380 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cefdinir
    Intervention Type
    Drug
    Intervention Name(s)
    cephalexin
    Primary Outcome Measure Information:
    Title
    Clinical cure rate
    Secondary Outcome Measure Information:
    Title
    Adverse event rates
    Title
    Bacteriologic cure rates
    Title
    Patient reported outcomes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Global Medical Information
    Organizational Affiliation
    Abbott
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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