Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (CLIN01)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Infections Obesity |
Drug: Clindamycin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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 |
- Clearance (Cl) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]
The PK schedule will be as follows:
Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs
- Volume of distribution (Vd) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]
The PK schedule will be as follows:
Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs
- Area under the curve (AUCtau) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]
The PK schedule will be as follows:
Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs
- Oral apparent clearance (Cl/F) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]
The PK schedule will be as follows:
Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs
- Oral apparent volume of distribution (V/F) [ Time Frame: A population PK analysis will be done so multiple timeframes will be included (0 hr; 0.5 hr; 1-1.5 hr; 3-4 hr and 5-6 hr post-dose) ] [ Designated as safety issue: No ]
The PK schedule will be as follows:
Pre-dose 0 (within 15 minutes prior to the dose) 0.5 (± 5 minutes) 1-1.5 hrs 3-4 hrs 5-6 hrs
- Number of Adverse Events [ Time Frame: First dose of study medication to 3 days after last dose of study medication ] [ Designated as safety issue: Yes ]
| Enrollment: | 22 |
| Study Start Date: | June 2013 |
| Study Completion Date: | August 2014 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Clindamycin
Clindamycin phosphate (intravenous) Clindamycin hydrochloride (oral capsules) Clindamycin palmitate (oral solution) 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. |
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:
|
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 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).
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- History of hypersensitivity or allergic reaction to clindamycin or lincomycin
- History of C. difficile colitis with previous administration of clindamycin
- Aspartate aminotransferase (AST) > 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01744730
| 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 | |
| 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
Additional Information:
No publications provided
| 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 |
| Study First Received: | December 5, 2012 |
| Last Updated: | November 17, 2014 |
| Health Authority: | United States: Food and Drug Administration United States: Data and Safety Monitoring Board United States: Institutional Review Board |
Keywords provided by Duke University:
|
Bacterial infections Obesity pharmacokinetics clindamycin |
Additional relevant MeSH terms:
|
Bacterial Infections Infection Obesity Body Weight Nutrition Disorders Overnutrition Overweight Signs and Symptoms Clindamycin |
Clindamycin palmitate Clindamycin phosphate Anti-Bacterial Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Synthesis Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015