Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Infectious Disease |
| Therapuetic Areas: | Endocrinology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 2/7/2015 |
| Start Date: | June 2013 |
| End Date: | September 2014 |
| Contact: | P. Brian Smith, MD, MHS, MPH |
| Email: | brian.smith@dm.duke.edu |
| Phone: | 919-668-8951 |
Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (NICHD): CLIN01
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.
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.
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).
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).
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
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