Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (CLIN01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01744730
First received: December 5, 2012
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

The purpose of this study is better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (a ratio of weight to height). The results of the study will help better understand if children in higher BMI ranges process the medication differently and whether dosing should be adjusted in these children.


Condition Intervention Phase
Bacterial Infections
Obesity
Drug: Clindamycin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (NICHD): CLIN01

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clearance (Cl) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]

    The PK schedule will be as follows:

    Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs


  • Volume of distribution (Vd) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]

    The PK schedule will be as follows:

    Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs


  • Area under the curve (AUCtau) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]

    The PK schedule will be as follows:

    Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs



Secondary Outcome Measures:
  • Oral apparent clearance (Cl/F) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]

    The PK schedule will be as follows:

    Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs


  • Oral apparent volume of distribution (V/F) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]

    The PK schedule will be as follows:

    Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs


  • Number of Adverse Events [ Time Frame: First dose of study medication to 3 days after last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: June 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clindamycin

Clindamycin phosphate (intravenous) Clindamycin hydrochloride (oral capsules) Clindamycin palmitate (oral solution)

Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.

Drug: Clindamycin
Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.
Other Names:
  • Clindamycin phosphate (intravenous)
  • Clindamycin hydrochloride (oral capsules)
  • Clindamycin palmitate (oral solution)

Detailed Description:

This is a prospective, open-label pharmacokinetic and safety study of multiple doses of IV and oral clindamycin in overweight and obese children 2 - < 18 years of age. The total study duration is expected to be approximately 24 months; each subject will participate in the study for up to 18 days (screening day; treatment days 1-14 [may be as short as 2 days] followed by an observation period of 3 days post discontinuation of clindamycin therapy or after day 17 (on day 18) of therapy in those who are treated with more than 14 days of clindamycin).

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2 years - < 18 years of age at the time of first dose of study drug
  • Suspected or confirmed infection OR receiving IV clindamycin per routine care
  • Negative serum pregnancy test (if female and has reached menarche) within 24 hours of first dose of study drug and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy test through the last dose of study drug
  • BMI ≥ 85th percentile for age and sex, based on Centers for Disease Control (CDC) recommendations
  • Signed informed consent/Health Insurance Portability and Accountability Act (HIPAA) documents by the parent/legal guardian and assent (if applicable)

Exclusion Criteria:

  • The following apply only to those who are NOT already receiving clindamycin per routine care:

    1. History of hypersensitivity or allergic reaction to clindamycin or lincomycin
    2. History of C. difficile colitis with previous administration of clindamycin
    3. Aspartate aminotransferase (AST) > 120 units/L
    4. Alanine aminotransferase (ALT) > 210 units/L
    5. Total bilirubin > 3 mg/dL
    6. Serum creatinine > 2 mg/dL
    7. Receiving a neuromuscular blocker as part of their therapy
  • Previous participation in the study
  • Subject is on prohibited medication or herbal product (see Appendix II)
  • Subject is receiving extracorporeal life support (ECLS)
  • Subject is post-cardiac bypass (within 24 hours)
  • Subject on inotropes/pressors
  • Any other condition or chronic illness that, in the opinion of the principal investigator, makes participation unadvised or unsafe
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744730

Contacts
Contact: P. Brian Smith, MD, MHS, MPH 919-668-8951 brian.smith@dm.duke.edu
Contact: Kevin Watt, MD 919-668-8556 kevin.watt@dm.duke.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Michael J Smith, MD, MSCE         
Principal Investigator: Michael J Smith, MD, MSCE         
Sponsors and Collaborators
Phillip Brian Smith
Investigators
Principal Investigator: P. Brian Smith, MD, MHS, MPH Duke Medical Center/Duke Clinical Research Institute
Principal Investigator: Kevin Watt, MD Duke Medical Center/Duke Clinical Research Institute
Principal Investigator: Michael J Smith, MD University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: Phillip Brian Smith, Associate Professor of Pediatrics, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01744730     History of Changes
Other Study ID Numbers: Pro00041855, HHSN275201000003I
Study First Received: December 5, 2012
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Duke University:
Bacterial infections
Obesity
pharmacokinetics
clindamycin

Additional relevant MeSH terms:
Bacterial Infections
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014