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Bacterial Infections | Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile

Bacterial Infections research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bacterial Infections

Obesity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ClindamycinSchedule 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

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.

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.

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.

Study Status

Completed

Start Date: June 2013

Completed Date: August 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: P. Brian Smith, MD, MHS, MPH

Lead Sponsor: Phillip Brian Smith

Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More information:https://clinicaltrials.gov/show/NCT01744730

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Gonzalez D, Melloni C, Yogev R, Poindexter BB, Mendley SR, Delmore P, Sullivan JE, Autmizguine J, Lewandowski A, Harper B, Watt KM, Lewis KC, Capparelli EV, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee. Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clin Pharmacol Ther. 2014 Oct;96(4):429-37. doi: 10.1038/clpt.2014.134. Epub 2014 Jun 20.

Gatti G, Flaherty J, Bubp J, White J, Borin M, Gambertoglio J. Comparative study of bioavailabilities and pharmacokinetics of clindamycin in healthy volunteers and patients with AIDS. Antimicrob Agents Chemother. 1993 May;37(5):1137-43.

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