Clinical trial NCT01744730: Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile
Official title: Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (NICHD): CLIN01
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bacterial Infections
Obesity
Keywords: Bacterial infections
Obesity
pharmacokinetics
clindamycin
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: The Emmes Company, LLC
First posted: 2012-12-07
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility 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

Primary outcomes:
measure: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
timeFrame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).
measure: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
timeFrame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
measure: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
timeFrame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
measure: PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
timeFrame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
measure: PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
timeFrame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
affiliation: Duke Medical Center/Duke Clinical Research Institute
name: P. Brian Smith, MD, MHS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Medical Center/Duke Clinical Research Institute
name: Kevin Watt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville
name: Michael J Smith, MD
role: PRINCIPAL_INVESTIGATOR
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