PK of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)

This study is currently recruiting participants.
Verified March 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01728363
First received: November 9, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

Multiple center, open-label, PK study


Condition Intervention Phase
Systemic Infection
Drug: Antibiotic
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Antistaphylococcal Antibiotics in Infants

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Pharmacokinetic concentrations in plasma will be measured at a central lab using a validated bioanalytical assay. Plasma samples will be drawn according to specific schedules for each drug [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    to determine the Pharmacokinetics of rifampin, ticarcillin-clavulanate, and clindamycin


Secondary Outcome Measures:
  • Safety review will be performed through monitoring of adverse events each day that the infant is on study [ Time Frame: 7 days after last study dose ] [ Designated as safety issue: No ]
    adverse events, serious adverse events, serious suspected adverse reactions, serious adverse reactions, suspected adverse reaction, adverse reactions will be assessed.


Estimated Enrollment: 96
Study Start Date: January 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticarcillin-clavulanate antibiotic

Cohort GA PNA Dose

  1. <30 weeks <14 days: 75 mg/kg Q12 hrs x 6 doses
  2. <30 weeks ≥14 days-45 days 75 mg/kg Q 8 hours x 6 doses
  3. <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.

Drug: Antibiotic
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.
Other Names:
  • Ticarcillin-clavulanate generic; Brand Timentin
  • Rifampin generic; Brand Rifadin, Rimatane
  • Clindamycin generic; Brand Cleocin
Experimental: Rifampin generic antibiotic

Cohort GA PNA Dose

  1. <32 weeks <14 days 10 mg/kg Q 24 hours x 4 doses
  2. <32 weeks ≥14 days-120 days 15 mg/kg Q 24 hours x 4 doses
  3. ≥32 weeks <14 days 15 mg/kg Q 24 hours x 4 doses
  4. ≥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.

Drug: Antibiotic
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.
Other Names:
  • Ticarcillin-clavulanate generic; Brand Timentin
  • Rifampin generic; Brand Rifadin, Rimatane
  • Clindamycin generic; Brand Cleocin
Experimental: Clindamycin Generic Antibiotic

Cohort GA PNA Dose

  1. <30 weeks <14 days 10 mg/kg Q 12 hours x 6 doses
  2. <30 weeks ≥14 days-45 days 10 mg/kg Q 8 hours x 6 doses
  3. <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.

Drug: Antibiotic
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.
Other Names:
  • Ticarcillin-clavulanate generic; Brand Timentin
  • Rifampin generic; Brand Rifadin, Rimatane
  • Clindamycin generic; Brand Cleocin

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sufficient intravascular access
  • Suspected systemic infection or receiving 1 of the study drugs per standard of care
  • informed consent from legal guardian

Exclusion Criteria:

  • history of allergic reaction to study drugs
  • urine output <0.5 mL/hr/kg over the prior 24 hours
  • serum creatinine >1.7 mg/dl
  • Any condition in investigator judgment precludes participation because it could affect participant safety
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01728363

Locations
United States, Florida
University of FL Recruiting
Gainesville, Florida, United States, 32610
Contact: David Burchfield, MD    352-273-8985    burchdj@peds.ufl.edu   
Contact: Kamia Morris    352-294-5171    klmorris@peds.ufl.edu   
UFL Health and Baptist Recruiting
Jacksonville, Florida, United States, 32209
Contact: Mark Hudak, MD    904-244-3508    mark.hudak@jak.ufl.edu   
Contact: Kimberly Barnette    904-244-7760    kimberly.barnette@jax.ufl.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Paul Spearman, MD    404-727-5642    paulspearman@emory.edu   
Contact: Brooke Hartwell, RN    404-727-5642      
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Brenda Poindexter, MD    317-274-4768    bpoindex@iu.edu   
Contact: Leslie D Wilson, RN    317-274-8255      
United States, Kansas
Wesley Medical Recruiting
Wichita, Kansas, United States, 67214
Contact: Bloom T Bloom, MD    316-259-0810    barrybloom@aol.com   
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Janice Sullivan, MD    502-852-3720    sully@louisville.edu   
Contact: Karen Kernen, RN    502-629-5044      
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Elisabeth McGowan, MD    617-240-4660      
Contact: Brittany Bressler, RN    617-636-1753      
United States, New York
Kings County Hospital Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Gratias Mundakel, MD    718-245-7048    gratias.mundakel@nychhc.org   
Contact: Subhatra Limbu    917-375-4145      
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Michael Cotten, MD    919-681-4913    cotte010@mc.duke.edu   
Contact: Cynthia Ross, RN    919-613-5158      
United States, Texas
University of Texas Children's Hospital Recruiting
Galveston, Texas, United States, 77555
Contact: Karen Shattuck, MD    409-772-2815    keshattu@utmb.edu   
Contact: Lori Simon, RN    409-747-9240      
Sponsors and Collaborators
Phillip Brian Smith
Investigators
Principal Investigator: Philip B Smith, MD Duke Clinical Research Institute and DUMC
  More Information

No publications provided

Responsible Party: Phillip Brian Smith, Principal Investigator, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01728363     History of Changes
Other Study ID Numbers: Pro00037820
Study First Received: November 9, 2012
Last Updated: March 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
Staphylococcal

Additional relevant MeSH terms:
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Ticarcillin
Clindamycin
Clindamycin-2-phosphate
Rifampin
Clavulanic Acids
Clavulanic Acid
Ticarcillin-clavulanic acid
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014