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Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (CLIN01)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Bacterial Infections Obesity | Drug: Clindamycin | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (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 |
- Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6). ]
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable.
- Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable.
- Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable.
- PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below.
Sampling schedule details for PTN_POPS and Staph Trio were comparable.
- PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. [ Time Frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). ]
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese & non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis.
PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below.
Sampling schedule details for PTN_POPS & Staph Trio were comparable.
| 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 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.
|
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:
|
|
Active Comparator: 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.
|
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:
|
|
Active Comparator: 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.
|
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:
|
|
Active Comparator: 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.
|
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:
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| 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:
Publications:
| 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 ( Other Identifier: National Institute of Child Health & Human Development ) |
| Study First Received: | December 5, 2012 |
| Results First Received: | February 10, 2016 |
| Last Updated: | November 21, 2016 |
Keywords provided by Phillip Brian Smith, Duke University Medical Center:
|
Bacterial infections Obesity pharmacokinetics clindamycin |
Additional relevant MeSH terms:
|
Bacterial Infections Clindamycin Clindamycin palmitate Clindamycin phosphate Anti-Bacterial Agents |
Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017