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

This study is currently recruiting participants.
Verified June 2013 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: June 12, 2013
Last verified: June 2013
History of Changes
  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:

U.S. FDA Resources

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 2014
Estimated Primary Completion Date: January 2014 (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, 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: Jennifer Lee, MD     617-240-4660     jlee9@tuftsmedicalcenter.org    
Contact: Brittany Bressler, RN     617-636-1753        
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: June 12, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
Staphylococcal

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

ClinicalTrials.gov processed this record on June 18, 2013