Phase 1
Completed N=200
Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile
Source: ClinicalTrials.gov NCT01744730 ↗Enrolled (actual)
200
Serious AEs
0.5%
Results posted
Oct 2016
Primary outcomePrimary: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. — 4.2; 5.7; 12.5; 10.7 L/h
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. |
10.6; 14.8; 20.7; 14.7; 15.8; 14 | — |
| PRIMARY Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. |
10.6; 14.8; 20.7; 14.7; 15.8; 14 | — |
| PRIMARY Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. |
10.6; 14.8; 20.7; 14.7; 15.8; 14 | — |
| PRIMARY PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. |
0.8; 0.9; 0.9; 1.0; 0.9; 0.9 | — |
| PRIMARY PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. |
0.8; 0.9; 0.9; 1.0; 0.9; 0.9 | — |
Eligibility Criteria
Inclusion Criteria
- 2 years - 120 units/L
- Alanine aminotransferase (ALT) > 210 units/L
- Total bilirubin > 3 mg/dL
- Serum creatinine > 2 mg/dL
- 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
Data sourced from ClinicalTrials.gov (NCT01744730). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.