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

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ClinicalTrials.gov Identifier: NCT01744730
Recruitment Status : Completed
First Posted : December 7, 2012
Results First Posted : October 19, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to better understand how clindamycin works in children who fall in the 85th percentile or higher for body mass index (BMI - 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 or disease Intervention/treatment Phase
Bacterial Infections Obesity Drug: Clindamycin Phase 1

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 ages 2 to 17 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).

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)
Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 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 was 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)
Active Comparator: Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)
Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 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 was 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)
Active Comparator: Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)
Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 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 was 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)
Active Comparator: Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)
Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 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 was 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)


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6). ]

    In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.

    PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below.

    Sampling schedule details for PTN_POPS and Staph Trio were comparable.


  2. Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]

    In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.

    PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below.

    Sampling schedule details for PTN_POPS and Staph Trio were comparable.


  3. Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]

    In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.

    PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below.

    Sampling schedule details for PTN_POPS and Staph Trio were comparable.


  4. PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]

    In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.

    PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below.

    Sampling schedule details for PTN_POPS and Staph Trio were comparable.


  5. PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]

    In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese & non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.

    PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below.

    Sampling schedule details for PTN_POPS & Staph Trio were comparable.



Eligibility Criteria
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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744730


Locations
United States, Illinois
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Kansas
Children's Mercy Hospital
Kansas City, Kansas, United States, 64108
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 48109
Sponsors and Collaborators
Phillip Brian Smith
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Pediatric Trials Network  This link exits the ClinicalTrials.gov site
National Institute for Child Health and Human Development  This link exits the ClinicalTrials.gov site
Clindamycin Injection (Package Insert). Schaumberg, IL: APP Pharmaceuticals; 2008  This link exits the ClinicalTrials.gov site

Publications of Results:

Other Publications:

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 ( Other Identifier: National Institute of Child Health & Human Development )
First Posted: December 7, 2012    Key Record Dates
Results First Posted: October 19, 2016
Last Update Posted: November 29, 2016
Last Verified: October 2016

Keywords provided by Phillip Brian Smith, Duke University Medical Center:
Bacterial infections
Obesity
pharmacokinetics
clindamycin

Additional relevant MeSH terms:
Bacterial Infections
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
 Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action