<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03802552</url>
  </required_header>
  <id_info>
    <org_study_id>18-2142</org_study_id>
    <nct_id>NCT03802552</nct_id>
  </id_info>
  <brief_title>Cefadroxil and Cephalexin Drug Levels and Dosing in Pediatric Musculoskeletal Infections</brief_title>
  <official_title>Comparative Pharmacokinetics and Pharmacodynamics (PK/PD) of Cefadroxil and Cephalexin for Pediatric Musculoskeletal (MSK) Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to figure out the best doses for two antibiotics (called cefadroxil&#xD;
      and cephalexin) when they are used to treat bone, joint, or muscle infections in children. In&#xD;
      order to do this, the study will collect data about children admitted to Children's Hospital&#xD;
      Colorado who have these types of infections. During the study, these patients will receive&#xD;
      doses by mouth of each of these antibiotics, in addition to an IV antibiotic (given through a&#xD;
      vein) used to treat their infection. After the dose of the first antibiotic, blood samples&#xD;
      will be drawn every few hours to measure how much of the drug is still in their body, until&#xD;
      it is all gone. After the first antibiotic is out of the patient's body, the same will be&#xD;
      done for the second antibiotic. Measurements, in the lab, of how much of these antibiotics&#xD;
      are needed to kill the most common bacteria causing these infections, which is a type of&#xD;
      &quot;Staph&quot; bacteria called &quot;MSSA&quot;, will be taken. Finally, the blood levels of the antibiotics&#xD;
      and the information from the lab tests about the Staph bacteria will be used to calculate how&#xD;
      much and how often of the antibiotic should be given to children with bone, joint, or muscle&#xD;
      infections. Currently, these types of infections are treated with an antibiotic that children&#xD;
      have to take four times every day. The goal of this study is to find an antibiotic that&#xD;
      children can take only two or three times per day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to shift the current treatment paradigm for the use of oral first-generation&#xD;
      cephalosporins in pediatric musculoskeletal (MSK) infections. Optimizing treatment for MSK&#xD;
      infections is particularly important, as osteomyelitis is one of the most common severe&#xD;
      infections affecting children. Treatment for these infections has markedly improved over the&#xD;
      last few decades, but significant morbidity is still seen, including the possibility of&#xD;
      permanent disability due to pathologic fracture, growth arrest, and joint destruction. To&#xD;
      avoid these long term sequelae and recrudescent infection, early diagnosis, appropriate&#xD;
      therapy, and prolonged treatment courses (typically 4-6 weeks, or longer) are essential.&#xD;
&#xD;
      The most commonly used antibiotic for MSK infections is cephalexin, a first-generation&#xD;
      cephalosporin. It is well tolerated, provides good tissue penetration, and has a preferred&#xD;
      spectrum of activity for typical MSK pathogens, including methicillin susceptible&#xD;
      Staphylococcus aureus (MSSA). Despite cephalexin's widespread use, its most significant&#xD;
      disadvantage is its short plasma half-life. Because of this, cephalexin is traditionally&#xD;
      dosed four times daily (QID) for serious infections like osteomyelitis. However, this dosing&#xD;
      frequency, especially for prolonged treatment courses, proves difficult for both patients and&#xD;
      their families. Concern about poor adherence drives some providers to prolong IV therapy or&#xD;
      dose cephalexin three times daily (TID), though there are insufficient&#xD;
      pharmacokinetic/pharmacodynamic (PK/PD) or outcome data to support TID dosing.&#xD;
&#xD;
      Cefadroxil, another first-generation cephalosporin, is an appealing alternative to cephalexin&#xD;
      due to its longer half-life. Because of this, the investigators hypothesize that cefadroxil&#xD;
      could be used effectively in pediatric patients with MSK infections with a more convenient&#xD;
      dosing schedule than cephalexin. While cephalexin is typically dosed 3-4 times per day,&#xD;
      cefadroxil could likely be dosed 2-3 times per day, even for serious infections like&#xD;
      osteomyelitis. However, cefadroxil is rarely prescribed to children due to a lack of&#xD;
      pediatric PK/PD data to guide dosing. Our study aims to address this unmet need and help&#xD;
      physicians use these existing drugs in smarter and more effective ways in pediatric MSK&#xD;
      infections.&#xD;
&#xD;
      The specific aims of this study are to:&#xD;
&#xD;
        1. Use a Population PK approach to define comparative PK parameters of cefadroxil and&#xD;
           cephalexin in pediatric patients with MSK infections (osteomyelitis, septic arthritis,&#xD;
           pyomyositis).&#xD;
&#xD;
        2. Establish reference MIC ranges for both cefadroxil and cephalexin against MSSA isolates.&#xD;
&#xD;
        3. Perform pharmacodynamic modeling (Monte Carlo simulation) based on the above PK&#xD;
           parameters and MIC data to evaluate the expected PK/PD target attainment of cefadroxil&#xD;
           and cephalexin at different dosing intervals: cephalexin given as 3 vs. 4 divided doses&#xD;
           per day; cefadroxil given as 2 vs. 3 doses against a range of MICs.&#xD;
&#xD;
      To answer these questions, patients with MSK infections admitted to Children's Hospital&#xD;
      Colorado (CHCO) will be enrolled in this study and sequentially given doses of both&#xD;
      cefadroxil and cephalexin. After each oral dose, serum levels of the antibiotic will be&#xD;
      measured at set time points until the drug is expected to be fully cleared. They will then&#xD;
      receive the second antibiotic after a 24-hour washout period. MIC ranges will be measured&#xD;
      based on banked MSSA isolates. Based on these study-derived PK and MIC data, adequacy of the&#xD;
      studied cephalexin and cefadroxil dosing regimens will be analyzed.&#xD;
&#xD;
      If the study is able to confirm a favorable PK/PD profile for twice daily (BID) and/or three&#xD;
      times daily (TID) cefadroxil dosing in children, even for severe infections, it could have an&#xD;
      immediate impact on prescribing habits. Less frequent dosing would be an improvement over the&#xD;
      current standard of care, allowing for easier medication administration, improved adherence,&#xD;
      and increased provider confidence for early transition to oral therapy, which are all&#xD;
      essential for optimal treatment of pediatric MSK infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time above Minimum Inhibitory Concentration (T &gt; MIC)</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>As a surrogate of treatment efficacy for cefadroxil and cephalexin, the investigators will measure the time that free serum concentrations (T &gt; MIC) of cefadroxil and cephalexin remain above the minimum inhibitory concentration (MIC) of MSSA. A range of MICs will be directly measured, with an expected range from 0.125 to 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL/F) of cefadroxil and cephalexin</measure>
    <time_frame>Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)</time_frame>
    <description>In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the Clearance, or CL/F (L/h/kg), of both drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution (V/F) of cefadroxil and cephalexin</measure>
    <time_frame>Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)</time_frame>
    <description>In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the Volume of Distribution, or V/F (L/kg), of both drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life (T1/2) of cefadroxil and cephalexin</measure>
    <time_frame>Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)</time_frame>
    <description>In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the half life, or T1/2 (hours), of both drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC) of cefadroxil and cephalexin</measure>
    <time_frame>Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)</time_frame>
    <description>In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the area under the curve, or AUC (h*mg/L), of both drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak serum drug concentration (Cmax) of cefadroxil and cephalexin</measure>
    <time_frame>Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)</time_frame>
    <description>In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the peak serum drug concentration, or Cmax (mg/L), of both drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum serum drug concentration (Cmin) of cefadroxil and cephalexin</measure>
    <time_frame>Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)</time_frame>
    <description>In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the minimum serum drug concentration, or Cmin (mg/L), of both drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time at which maximal drug concentration is achieved (Tmax) of cefadroxil and cephalexin</measure>
    <time_frame>Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)</time_frame>
    <description>In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the time at which maximal drug concentration is achieved, or Tmax (hours), of both drugs.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Osteomyelitis</condition>
  <condition>Septic Arthritis</condition>
  <condition>Pyomyositis</condition>
  <arm_group>
    <arm_group_label>Cefadroxil then Cephalexin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive cefadroxil first, then receive cephalexin after washout.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cephalexin then Cefadroxil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive cephalexin first, then receive cefadroxil after washout.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefadroxil</intervention_name>
    <description>oral one-time dose of cefadroxil</description>
    <arm_group_label>Cefadroxil then Cephalexin</arm_group_label>
    <arm_group_label>Cephalexin then Cefadroxil</arm_group_label>
    <other_name>Duricef</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cephalexin</intervention_name>
    <description>oral one-time dose of cephalexin</description>
    <arm_group_label>Cefadroxil then Cephalexin</arm_group_label>
    <arm_group_label>Cephalexin then Cefadroxil</arm_group_label>
    <other_name>Keflex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children who are admitted to Children's Hospital Colorado and:&#xD;
&#xD;
          -  Are to be treated for a deep musculoskeletal infection (osteomyelitis, septic&#xD;
             arthritis, pyomyositis), as determined by their primary medical team&#xD;
&#xD;
          -  Are aged 6 months to 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they:&#xD;
&#xD;
          -  Are less than 6 months of age or greater than 18 years of age&#xD;
&#xD;
          -  Weigh less than 5.5 kg&#xD;
&#xD;
          -  Weigh greater than the 95%ile for age&#xD;
&#xD;
          -  Have underlying current renal disease based on medical history&#xD;
&#xD;
          -  Have an underlying chronic medical condition-examples include cystic fibrosis, sickle&#xD;
             cell anemia, inflammatory bowel disease, pancreatitis, hepatitis, immunodeficiency,&#xD;
             cancer, spina bifida, chromosomal abnormalities, cerebral palsy, or metabolic&#xD;
             disorders.&#xD;
&#xD;
          -  Have a history of significant drug allergy to any beta-lactam antibiotic (e.g.&#xD;
             anaphylaxis and/or angioedema)&#xD;
&#xD;
          -  Are on an oral cephalosporin at time of enrollment&#xD;
&#xD;
          -  Are started on an oral cephalosporin during the study&#xD;
&#xD;
             o Note: If an enrolled patient is started on an oral cephalosporin prior to completion&#xD;
             of the study, they will be removed from the study. However, data obtained prior to&#xD;
             their receipt of an oral cephalosporin will still be included in the analysis.&#xD;
&#xD;
          -  Are known to be pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Haynes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>May 28, 2021</last_update_submitted>
  <last_update_submitted_qc>May 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Pyomyositis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cephalexin</mesh_term>
    <mesh_term>Cefadroxil</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03802552
org study id: 18-2142
nct id: NCT03802552
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The goal of this study is to figure out the best doses for two antibiotics (called cefadroxil
      and cephalexin) when they are used to treat bone, joint, or muscle infections in children. In
      order to do this, the study will collect data about children admitted to Children's Hospital
      Colorado who have these types of infections. During the study, these patients will receive
      doses by mouth of each of these antibiotics, in addition to an IV antibiotic (given through a
      vein) used to treat their infection. After the dose of the first antibiotic, blood samples
      will be drawn every few hours to measure how much of the drug is still in their body, until
      it is all gone. After the first antibiotic is out of the patient's body, the same will be
      done for the second antibiotic. Measurements, in the lab, of how much of these antibiotics
      are needed to kill the most common bacteria causing these infections, which is a type of
      "Staph" bacteria called "MSSA", will be taken. Finally, the blood levels of the antibiotics
      and the information from the lab tests about the Staph bacteria will be used to calculate how
      much and how often of the antibiotic should be given to children with bone, joint, or muscle
      infections. Currently, these types of infections are treated with an antibiotic that children
      have to take four times every day. The goal of this study is to find an antibiotic that
      children can take only two or three times per day.
This study aims to shift the current treatment paradigm for the use of oral first-generation
      cephalosporins in pediatric musculoskeletal (MSK) infections. Optimizing treatment for MSK
      infections is particularly important, as osteomyelitis is one of the most common severe
      infections affecting children. Treatment for these infections has markedly improved over the
      last few decades, but significant morbidity is still seen, including the possibility of
      permanent disability due to pathologic fracture, growth arrest, and joint destruction. To
      avoid these long term sequelae and recrudescent infection, early diagnosis, appropriate
      therapy, and prolonged treatment courses (typically 4-6 weeks, or longer) are essential.

      The most commonly used antibiotic for MSK infections is cephalexin, a first-generation
      cephalosporin. It is well tolerated, provides good tissue penetration, and has a preferred
      spectrum of activity for typical MSK pathogens, including methicillin susceptible
      Staphylococcus aureus (MSSA). Despite cephalexin's widespread use, its most significant
      disadvantage is its short plasma half-life. Because of this, cephalexin is traditionally
      dosed four times daily (QID) for serious infections like osteomyelitis. However, this dosing
      frequency, especially for prolonged treatment courses, proves difficult for both patients and
      their families. Concern about poor adherence drives some providers to prolong IV therapy or
      dose cephalexin three times daily (TID), though there are insufficient
      pharmacokinetic/pharmacodynamic (PK/PD) or outcome data to support TID dosing.

      Cefadroxil, another first-generation cephalosporin, is an appealing alternative to cephalexin
      due to its longer half-life. Because of this, the investigators hypothesize that cefadroxil
      could be used effectively in pediatric patients with MSK infections with a more convenient
      dosing schedule than cephalexin. While cephalexin is typically dosed 3-4 times per day,
      cefadroxil could likely be dosed 2-3 times per day, even for serious infections like
      osteomyelitis. However, cefadroxil is rarely prescribed to children due to a lack of
      pediatric PK/PD data to guide dosing. Our study aims to address this unmet need and help
      physicians use these existing drugs in smarter and more effective ways in pediatric MSK
      infections.

      The specific aims of this study are to:

        1. Use a Population PK approach to define comparative PK parameters of cefadroxil and
           cephalexin in pediatric patients with MSK infections (osteomyelitis, septic arthritis,
           pyomyositis).

        2. Establish reference MIC ranges for both cefadroxil and cephalexin against MSSA isolates.

        3. Perform pharmacodynamic modeling (Monte Carlo simulation) based on the above PK
           parameters and MIC data to evaluate the expected PK/PD target attainment of cefadroxil
           and cephalexin at different dosing intervals: cephalexin given as 3 vs. 4 divided doses
           per day; cefadroxil given as 2 vs. 3 doses against a range of MICs.

      To answer these questions, patients with MSK infections admitted to Children's Hospital
      Colorado (CHCO) will be enrolled in this study and sequentially given doses of both
      cefadroxil and cephalexin. After each oral dose, serum levels of the antibiotic will be
      measured at set time points until the drug is expected to be fully cleared. They will then
      receive the second antibiotic after a 24-hour washout period. MIC ranges will be measured
      based on banked MSSA isolates. Based on these study-derived PK and MIC data, adequacy of the
      studied cephalexin and cefadroxil dosing regimens will be analyzed.

      If the study is able to confirm a favorable PK/PD profile for twice daily (BID) and/or three
      times daily (TID) cefadroxil dosing in children, even for severe infections, it could have an
      immediate impact on prescribing habits. Less frequent dosing would be an improvement over the
      current standard of care, allowing for easier medication administration, improved adherence,
      and increased provider confidence for early transition to oral therapy, which are all
      essential for optimal treatment of pediatric MSK infections.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Time above Minimum Inhibitory Concentration (T > MIC)
time frame: up to 24 hours
description: As a surrogate of treatment efficacy for cefadroxil and cephalexin, the investigators will measure the time that free serum concentrations (T > MIC) of cefadroxil and cephalexin remain above the minimum inhibitory concentration (MIC) of MSSA. A range of MICs will be directly measured, with an expected range from 0.125 to 4.
measure: Clearance (CL/F) of cefadroxil and cephalexin
time frame: Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)
description: In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the Clearance, or CL/F (L/h/kg), of both drugs.
measure: Volume of Distribution (V/F) of cefadroxil and cephalexin
time frame: Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)
description: In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the Volume of Distribution, or V/F (L/kg), of both drugs.
measure: Half life (T1/2) of cefadroxil and cephalexin
time frame: Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)
description: In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the half life, or T1/2 (hours), of both drugs.
measure: Area under the curve (AUC) of cefadroxil and cephalexin
time frame: Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)
description: In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the area under the curve, or AUC (h*mg/L), of both drugs.
measure: Peak serum drug concentration (Cmax) of cefadroxil and cephalexin
time frame: Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)
description: In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the peak serum drug concentration, or Cmax (mg/L), of both drugs.
measure: Minimum serum drug concentration (Cmin) of cefadroxil and cephalexin
time frame: Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)
description: In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the minimum serum drug concentration, or Cmin (mg/L), of both drugs.
measure: Time at which maximal drug concentration is achieved (Tmax) of cefadroxil and cephalexin
time frame: Serum drug levels obtained at: 1, 2, 6, 8 hours (cephalexin); and 1, 2, 6, 8, 12 hours (cefadroxil)
description: In defining pharmacokinetic parameters for both cephalexin and cefadroxil, the investigators will assess the time at which maximal drug concentration is achieved, or Tmax (hours), of both drugs.
arm group label: Cefadroxil then Cephalexin
arm group type: Experimental
description: Receive cefadroxil first, then receive cephalexin after washout.
arm group label: Cephalexin then Cefadroxil
arm group type: Experimental
description: Receive cephalexin first, then receive cefadroxil after washout.
intervention type: Drug
intervention name: Cefadroxil
description: oral one-time dose of cefadroxil
arm group label: Cefadroxil then Cephalexin
arm group label: Cephalexin then Cefadroxil
other name: Duricef
intervention type: Drug
intervention name: Cephalexin
description: oral one-time dose of cephalexin
arm group label: Cefadroxil then Cephalexin
arm group label: Cephalexin then Cefadroxil
other name: Keflex
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: No
last name: Andrew Haynes, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteomyelitis
mesh term: Arthritis, Infectious
mesh term: Pyomyositis
mesh term: Cephalexin
mesh term: Cefadroxil
sharing ipd: No