<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/NCT01728363</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00037820</org_study_id>
    <nct_id>NCT01728363</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)</brief_title>
  <acronym>Staph</acronym>
  <official_title>Pharmacokinetics of Antistaphylococcal Antibiotics in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Phillip Brian Smith</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple center, open-label, PK study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in&#xD;
      hospitalized infants with suspected systemic infection or receiving one of the study drugs&#xD;
      per local standard of care. Number of participants are 16-32 evaluable per each study drug of&#xD;
      rifampin, ticarcillin-clavulanate, and clindamycin antibiotics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin</measure>
    <time_frame>72 hours</time_frame>
    <description>Pharmacometric analysis of area under the curve at steady state for cohort 1 participants who were dosed with rifampin 10mg/kg Q 24 hours x 4 doses (GA &lt; 32 weeks, PNA &lt; 14 days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1: Maximum concentration (Cmax) of rifampin</measure>
    <time_frame>72 hours</time_frame>
    <description>Pharmacometric analysis of maximum concentration after first dose for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA &lt; 32 weeks, PNA &lt; 14 days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1: Clearance (CL) of rifampin</measure>
    <time_frame>72 hours</time_frame>
    <description>Pharmacometric analysis of the clearance for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA &lt; 32 weeks, PNA &lt; 14 days)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cohort 1: Volume of distribution at steady state (Vss) of rifampin</measure>
    <time_frame>72 hours</time_frame>
    <description>Pharmacometric analysis of volume of distribution at steady state for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA &lt; 32 weeks, PNA &lt; 14 days)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohort 1: Adverse events for participants receiving rifampin</measure>
    <time_frame>7 days after last study dose</time_frame>
    <description>Adverse events experienced by cohort 1 participants receiving rifampin 10 mg/kg Q 24 hours x 4 doses (GA &lt; 32 weeks, PNA &gt; 14 days). An adverse event is any untoward medical occurrence in humans, whether or not considered drug-related, that occurs during the conduct of a clinical trial. Any change in clinical status (routine labs, physical examinations, etc.) that is considered clinically significant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 1 participants: serious adverse events for participants receiving rifampin</measure>
    <time_frame>7 days after last study dose</time_frame>
    <description>Serious adverse events experienced by cohort 1 participants receiving rifampin 10 mg/kg Q 24 hours x 4 doses(GA &lt; 32 weeks, PNA &gt; 14 days)Any event that results in any of the following outcomes: death, life-threatening adverse vent, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, inpatient hospitalization or prolongation of existing hospitalization, or important medical event that may jeopardize the health of the study participant or require medical or surgical intervention to prevent another outcome listed above</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Systemic Infection</condition>
  <arm_group>
    <arm_group_label>Ticarcillin-clavulanate antibiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort Gestational Age (GA) Postnatal Age (PNA) Dose&#xD;
&lt;30 weeks &lt;14 days: 75 mg/kg Q12 hrs x 6 doses&#xD;
&lt;30 weeks ≥14 days-45 days 75 mg/kg Q 8 hours x 6 doses&#xD;
&lt;30 weeks &gt;45 days-90 days 75 mg/kg Q 6 hours x 6 doses&#xD;
Brand name is Timentin. This drug is an antibiotic used to treat a wide variety of bacterial infections. It is a combination of two drugs &amp; both treat bacterial infections. Ticarcillin is a penicillin-type antibiotic that stops bacterial growth &amp; clavulanate potassium is an enzyme inhibitor that helps the ticarcillin work better.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rifampin generic antibiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort GA PNA Dose&#xD;
&lt;32 weeks &lt;14 days 10 mg/kg Q 24 hours x 4 doses&#xD;
&lt;32 weeks ≥14 days-120 days 15 mg/kg Q 24 hours x 4 doses&#xD;
≥32 weeks &lt;14 days 15 mg/kg Q 24 hours x 4 doses&#xD;
≥32 weeks ≥14 days-120 days 20 mg/kg Q 24 hours x 4 doses&#xD;
The brand name is Rifadin, Rimatane. This drug is an antibiotic and a first line antituberculotic and unlabeled use for infections caused by staphylococcus aureus &amp; staphylococcus epidermis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clindamycin Generic Antibiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort GA PNA Dose&#xD;
&lt;30 weeks &lt;14 days 10 mg/kg Q 12 hours x 6 doses&#xD;
&lt;30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses&#xD;
&lt;30 weeks &gt;45 days-120 days 10 mg/kg Q 6 hours x 6 doses&#xD;
The brand name is Cleocin. This drug is an antibiotic used to treat a wide variety of bacterial infections and serious infections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antibiotic</intervention_name>
    <description>Ticarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections.</description>
    <arm_group_label>Clindamycin Generic Antibiotic</arm_group_label>
    <arm_group_label>Rifampin generic antibiotic</arm_group_label>
    <arm_group_label>Ticarcillin-clavulanate antibiotic</arm_group_label>
    <other_name>Ticarcillin-clavulanate generic; Brand Timentin</other_name>
    <other_name>Rifampin generic; Brand Rifadin, Rimatane</other_name>
    <other_name>Clindamycin generic; Brand Cleocin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sufficient intravascular access&#xD;
&#xD;
          -  Suspected systemic infection or receiving 1 of the study drugs per standard of care&#xD;
&#xD;
          -  informed consent from legal guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of allergic reaction to study drugs&#xD;
&#xD;
          -  urine output &lt;0.5 mL/hr/kg over the prior 24 hours&#xD;
&#xD;
          -  serum creatinine &gt;1.7 mg/dl&#xD;
&#xD;
          -  Any condition in investigator judgment precludes participation because it could affect&#xD;
             participant safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Days</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip B Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Clinical Research Institute and DUMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of FL</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UFL Health and Baptist</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wesley Medical</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings County Hospital Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Children's Hospital</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Maharaj AR, Gonzalez D, Cohen-Wolkowiez M, Hornik CP, Edginton AN. Improving Pediatric Protein Binding Estimates: An Evaluation of alpha1-Acid Glycoprotein Maturation in Healthy and Infected Subjects. Clin Pharmacokinet. 2018 May;57(5):577-589. doi: 10.1007/s40262-017-0576-7.</citation>
    <PMID>28779462</PMID>
  </reference>
  <results_reference>
    <citation>Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.</citation>
    <PMID>26926644</PMID>
  </results_reference>
  <results_reference>
    <citation>Smith PB, Cotten CM, Hudak ML, Sullivan JE, Poindexter BB, Cohen-Wolkowiez M, Boakye-Agyeman F, Lewandowski A, Anand R, Benjamin DK Jr, Laughon MM; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Rifampin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2019 May 24;63(6):e00284-19. doi: 10.1128/AAC.00284-19. Print 2019 Jun.</citation>
    <PMID>30910891</PMID>
  </results_reference>
  <results_reference>
    <citation>Watt KM, Hornik CP, Balevic SJ, Mundakel G, Cotten CM, Harper B, Benjamin DK Jr, Anand R, Laughon M, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Pharmacokinetics of ticarcillin-clavulanate in premature infants. Br J Clin Pharmacol. 2019 May;85(5):1021-1027. doi: 10.1111/bcp.13882. Epub 2019 Mar 6.</citation>
    <PMID>30710387</PMID>
  </results_reference>
  <results_reference>
    <citation>Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny K, Benjamin DK Jr, Smith PB, Cohen-Wolkowiez M, Watt K; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Pharmacokinetics of Clindamycin in Obese and Nonobese Children. Antimicrob Agents Chemother. 2017 Mar 24;61(4):e02014-16. doi: 10.1128/AAC.02014-16. Print 2017 Apr.</citation>
    <PMID>28137820</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Phillip Brian Smith</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Staphylococcal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Rifampin</mesh_term>
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
    <mesh_term>Ticarcillin</mesh_term>
    <mesh_term>Ticarcillin-clavulanic acid</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 3, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT01728363/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT01728363
org study id: Pro00037820
nct id: NCT01728363
lead sponsor: 
has dmc: Yes
Multiple center, open-label, PK study
Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin antibiotics in
      hospitalized infants with suspected systemic infection or receiving one of the study drugs
      per local standard of care. Number of participants are 16-32 evaluable per each study drug of
      rifampin, ticarcillin-clavulanate, and clindamycin antibiotics.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cohort 1: Area under the curve infinity (AUCinfinity) for rifampin
time frame: 72 hours
description: Pharmacometric analysis of area under the curve at steady state for cohort 1 participants who were dosed with rifampin 10mg/kg Q 24 hours x 4 doses (GA < 32 weeks, PNA < 14 days)
measure: Cohort 1: Maximum concentration (Cmax) of rifampin
time frame: 72 hours
description: Pharmacometric analysis of maximum concentration after first dose for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA < 32 weeks, PNA < 14 days)
measure: Cohort 1: Clearance (CL) of rifampin
time frame: 72 hours
description: Pharmacometric analysis of the clearance for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA < 32 weeks, PNA < 14 days)
measure: Cohort 1: Volume of distribution at steady state (Vss) of rifampin
time frame: 72 hours
description: Pharmacometric analysis of volume of distribution at steady state for cohort 1 participants who were dosed with rifampin 10 mg/kg Q 24 hours x 4 doses (GA < 32 weeks, PNA < 14 days)
measure: Cohort 1: Adverse events for participants receiving rifampin
time frame: 7 days after last study dose
description: Adverse events experienced by cohort 1 participants receiving rifampin 10 mg/kg Q 24 hours x 4 doses (GA < 32 weeks, PNA > 14 days). An adverse event is any untoward medical occurrence in humans, whether or not considered drug-related, that occurs during the conduct of a clinical trial. Any change in clinical status (routine labs, physical examinations, etc.) that is considered clinically significant
measure: Cohort 1 participants: serious adverse events for participants receiving rifampin
time frame: 7 days after last study dose
description: Serious adverse events experienced by cohort 1 participants receiving rifampin 10 mg/kg Q 24 hours x 4 doses(GA < 32 weeks, PNA > 14 days)Any event that results in any of the following outcomes: death, life-threatening adverse vent, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, inpatient hospitalization or prolongation of existing hospitalization, or important medical event that may jeopardize the health of the study participant or require medical or surgical intervention to prevent another outcome listed above
arm group label: Ticarcillin-clavulanate antibiotic
arm group type: Experimental
description: Cohort Gestational Age (GA) Postnatal Age (PNA) Dose
<30 weeks <14 days: 75 mg/kg Q12 hrs x 6 doses
<30 weeks ≥14 days-45 days 75 mg/kg Q 8 hours x 6 doses
<30 weeks >45 days-90 days 75 mg/kg Q 6 hours x 6 doses
Brand name is Timentin. This drug is an antibiotic used to treat a wide variety of bacterial infections. It is a combination of two drugs & both treat bacterial infections. Ticarcillin is a penicillin-type antibiotic that stops bacterial growth & clavulanate potassium is an enzyme inhibitor that helps the ticarcillin work better.
arm group label: Rifampin generic antibiotic
arm group type: Experimental
description: Cohort GA PNA Dose
<32 weeks <14 days 10 mg/kg Q 24 hours x 4 doses
<32 weeks ≥14 days-120 days 15 mg/kg Q 24 hours x 4 doses
≥32 weeks <14 days 15 mg/kg Q 24 hours x 4 doses
≥32 weeks ≥14 days-120 days 20 mg/kg Q 24 hours x 4 doses
The brand name is Rifadin, Rimatane. This drug is an antibiotic and a first line antituberculotic and unlabeled use for infections caused by staphylococcus aureus & staphylococcus epidermis.
arm group label: Clindamycin Generic Antibiotic
arm group type: Experimental
description: Cohort GA PNA Dose
<30 weeks <14 days 10 mg/kg Q 12 hours x 6 doses
<30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses
<30 weeks >45 days-120 days 10 mg/kg Q 6 hours x 6 doses
The brand name is Cleocin. This drug is an antibiotic used to treat a wide variety of bacterial infections and serious infections.
intervention type: Drug
intervention name: Antibiotic
description: Ticarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections.
arm group label: Clindamycin Generic Antibiotic
arm group label: Rifampin generic antibiotic
arm group label: Ticarcillin-clavulanate antibiotic
other name: Ticarcillin-clavulanate generic; Brand Timentin
other name: Rifampin generic; Brand Rifadin, Rimatane
other name: Clindamycin generic; Brand Cleocin
criteria: 
gender: All
minimum age: 14 Days
maximum age: 32 Weeks
healthy volunteers: No
last name: Philip B Smith, MD
role: Principal Investigator
affiliation: Duke Clinical Research Institute and DUMC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Maharaj AR, Gonzalez D, Cohen-Wolkowiez M, Hornik CP, Edginton AN. Improving Pediatric Protein Binding Estimates: An Evaluation of alpha1-Acid Glycoprotein Maturation in Healthy and Infected Subjects. Clin Pharmacokinet. 2018 May;57(5):577-589. doi: 10.1007/s40262-017-0576-7.
PMID: 28779462
citation: Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.
PMID: 26926644
citation: Smith PB, Cotten CM, Hudak ML, Sullivan JE, Poindexter BB, Cohen-Wolkowiez M, Boakye-Agyeman F, Lewandowski A, Anand R, Benjamin DK Jr, Laughon MM; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Rifampin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2019 May 24;63(6):e00284-19. doi: 10.1128/AAC.00284-19. Print 2019 Jun.
PMID: 30910891
citation: Watt KM, Hornik CP, Balevic SJ, Mundakel G, Cotten CM, Harper B, Benjamin DK Jr, Anand R, Laughon M, Smith PB, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Steering Committee. Pharmacokinetics of ticarcillin-clavulanate in premature infants. Br J Clin Pharmacol. 2019 May;85(5):1021-1027. doi: 10.1111/bcp.13882. Epub 2019 Mar 6.
PMID: 30710387
citation: Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny K, Benjamin DK Jr, Smith PB, Cohen-Wolkowiez M, Watt K; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Pharmacokinetics of Clindamycin in Obese and Nonobese Children. Antimicrob Agents Chemother. 2017 Mar 24;61(4):e02014-16. doi: 10.1128/AAC.02014-16. Print 2017 Apr.
PMID: 28137820
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: Phillip Brian Smith
investigator title: Principal Investigator
mesh term: Sepsis
mesh term: Anti-Bacterial Agents
mesh term: Rifampin
mesh term: Clindamycin
mesh term: Clavulanic Acid
mesh term: Ticarcillin
mesh term: Ticarcillin-clavulanic acid
provided document: 