Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HHSN275201000003I | Other Identifier | National Institute of Child Health & Human Development |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| The Emmes Company, LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a prospective, open-label pharmacokinetic and safety study of multiple doses of IV and oral clindamycin in overweight and obese children ages 2 to 17 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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile) | Active Comparator | 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) | Active Comparator | 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) | Active Comparator | 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) | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clindamycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6). |
| Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
The following apply only to those who are NOT already receiving clindamycin per routine care:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Children's Mercy Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19463065 | Background | Gerber JS, Coffin SE, Smathers SA, Zaoutis TE. Trends in the incidence of methicillin-resistant Staphylococcus aureus infection in children's hospitals in the United States. Clin Infect Dis. 2009 Jul 1;49(1):65-71. doi: 10.1086/599348. | |
| 20478934 | Background | Herigon JC, Hersh AL, Gerber JS, Zaoutis TE, Newland JG. Antibiotic management of Staphylococcus aureus infections in US children's hospitals, 1999-2008. Pediatrics. 2010 Jun;125(6):e1294-300. doi: 10.1542/peds.2009-2867. Epub 2010 May 17. |
| Label | URL |
|---|---|
| Pediatric Trials Network | View source |
Not provided
Patients between the ages (and inclusive of these ages) of 2 years to 17 years at time of first dose of study medication were screened for all other inclusion and exclusion criteria which includes must have body mass index (BMI) greater than or equal to 85th percentile for age and sex, based on Centers for Disease Control (CDC) recommendations.
Eligible participants (inpatients) were recruited in 4 hospitals in the United States. All participants were required to be receiving intravenous (IV) Clindamycin.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Patients Less Than 21 Years of Age (NCT01431326) | Standard of care clindamycin administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status. | Posted | Median | Full Range | L/h | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6). |
Safety was assessed from the time of informed consent, up to 13 days after completion of the last study dose or early termination (approximately 30 days).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clindamycin IV-ages 2 to 11 (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 PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) |
Data from 3 different studies was included to increase the robustness of the population PK model developed and leverage all available clindamycin PK data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Watt, MD | Duke Clinical Research Institute, Duke University School of Medicine | 919-668-8556 | kevin.watt@dm.duke.edu |
Not provided
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D050177 | Overweight |
| D044343 | Overnutrition |
Not provided
Not provided
| ID | Term |
|---|---|
| D002981 | Clindamycin |
| C007084 | clindamycin phosphate |
| C000489 | clindamycin palmitate |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. |
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. |
| After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
| PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
| PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
| Kansas City |
| Kansas |
| 64108 |
| United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Akron Children's Hospital | Akron | Ohio | 48109 | United States |
| 22253364 | Background | Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010. JAMA. 2012 Feb 1;307(5):483-90. doi: 10.1001/jama.2012.40. Epub 2012 Jan 17. |
| 10473362 | Background | Kasten MJ. Clindamycin, metronidazole, and chloramphenicol. Mayo Clin Proc. 1999 Aug;74(8):825-33. doi: 10.4065/74.8.825. |
| 17655508 | Background | Pai MP, Bearden DT. Antimicrobial dosing considerations in obese adult patients. Pharmacotherapy. 2007 Aug;27(8):1081-91. doi: 10.1592/phco.27.8.1081. |
| 10843460 | Background | Bearden DT, Rodvold KA. Dosage adjustments for antibacterials in obese patients: applying clinical pharmacokinetics. Clin Pharmacokinet. 2000 May;38(5):415-26. doi: 10.2165/00003088-200038050-00003. |
| 16790384 | Background | Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006 Jul;6(7):438-46. doi: 10.1016/S1473-3099(06)70523-0. |
| 22477819 | Background | Reed MD. Reversing the myths obstructing the determination of optimal age- and disease-based drug dosing in pediatrics. J Pediatr Pharmacol Ther. 2011 Jan;16(1):4-13. |
| 12839703 | Background | Jacobs MR. How can we predict bacterial eradication? Int J Infect Dis. 2003 Mar;7 Suppl 1:S13-20. doi: 10.1016/s1201-9712(03)90066-x. |
| 20975453 | Background | Bradley JS, Garonzik SM, Forrest A, Bhavnani SM. Pharmacokinetics, pharmacodynamics, and Monte Carlo simulation: selecting the best antimicrobial dose to treat an infection. Pediatr Infect Dis J. 2010 Nov;29(11):1043-6. doi: 10.1097/INF.0b013e3181f42a53. No abstract available. |
| 6470871 | Background | Bell MJ, Shackelford P, Smith R, Schroeder K. Pharmacokinetics of clindamycin phosphate in the first year of life. J Pediatr. 1984 Sep;105(3):482-6. doi: 10.1016/s0022-3476(84)80033-5. |
| 3737273 | Background | Koren G, Zarfin Y, Maresky D, Spiro TE, MacLeod SM. Pharmacokinetics of intravenous clindamycin in newborn infants. Pediatr Pharmacol (New York). 1986;5(4):287-92. |
| 4480976 | Background | DeHaan RM, Schellenberg D. Clindamycin palmitate flavored granules. Multidose tolerance, absorption, and urinary excretion study in healthy children. J Clin Pharmacol New Drugs. 1972 Feb-Mar;12(2):74-83. doi: 10.1002/j.1552-4604.1972.tb00149.x. No abstract available. |
| 4488654 | Background | DeHaan RM, Metzler CM, Schellenberg D, Vandenbosch WD. Pharmacokinetic studies of clindamycin phosphate. J Clin Pharmacol. 1973 May-Jun;13(5):190-209. doi: 10.1002/j.1552-4604.1973.tb00208.x. No abstract available. |
| 18623043 | Background | del Carmen Carrasco-Portugal M, Lujan M, Flores-Murrieta FJ. Evaluation of gender in the oral pharmacokinetics of clindamycin in humans. Biopharm Drug Dispos. 2008 Oct;29(7):427-30. doi: 10.1002/bdd.624. |
| 4638969 | Background | DeHaan RM, Metzler CM, Schellenberg D, VandenBosch WD, Masson EL. Pharmacokinetic studies of clindamycin hydrochloride in humans. Int J Clin Pharmacol. 1972 Jun;6(2):105-19. No abstract available. |
| 3569028 | Background | Townsend RJ, Baker RP. Pharmacokinetic comparison of three clindamycin phosphate dosing schedules. Drug Intell Clin Pharm. 1987 Mar;21(3):279-81. doi: 10.1177/106002808702100310. |
| 12814964 | Background | Wynalda MA, Hutzler JM, Koets MD, Podoll T, Wienkers LC. In vitro metabolism of clindamycin in human liver and intestinal microsomes. Drug Metab Dispos. 2003 Jul;31(7):878-87. doi: 10.1124/dmd.31.7.878. |
| 12496756 | Background | Green B, Duffull S. Caution when lean body weight is used as a size descriptor for obese subjects. Clin Pharmacol Ther. 2002 Dec;72(6):743-4. doi: 10.1067/mcp.2002.129306. No abstract available. |
| 12434728 | Background | Erstad BL. Which weight for weight-based dosage regimens in obese patients? Am J Health Syst Pharm. 2002 Nov 1;59(21):2105-10. doi: 10.1093/ajhp/59.21.2105. No abstract available. |
| 18465214 | Background | Weiss M. How does obesity affect residence time dispersion and the shape of drug disposition curves? Thiopental as an example. J Pharmacokinet Pharmacodyn. 2008 Jun;35(3):325-36. doi: 10.1007/s10928-008-9090-8. Epub 2008 May 9. |
| 21254063 | Background | Berezhkovskiy LM. On the accuracy of estimation of basic pharmacokinetic parameters by the traditional noncompartmental equations and the prediction of the steady-state volume of distribution in obese patients based upon data derived from normal subjects. J Pharm Sci. 2011 Jun;100(6):2482-97. doi: 10.1002/jps.22444. Epub 2011 Jan 19. |
| 21417960 | Background | Morrish GA, Pai MP, Green B. The effects of obesity on drug pharmacokinetics in humans. Expert Opin Drug Metab Toxicol. 2011 Jun;7(6):697-706. doi: 10.1517/17425255.2011.570331. Epub 2011 Mar 22. |
| 21516911 | Background | Leykin Y, Miotto L, Pellis T. Pharmacokinetic considerations in the obese. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):27-36. doi: 10.1016/j.bpa.2010.12.002. |
| 943947 | Background | Weinstein AJ, Gibbs RS, Gallagher M. Placental transfer of clindamycin and gentamicin in term pregnancy. Am J Obstet Gynecol. 1976 Apr 1;124(7):688-91. doi: 10.1016/s0002-9378(16)33336-1. |
| 24949994 | Result | 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. |
| 8517703 | Result | 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. doi: 10.1128/AAC.37.5.1137. |
| National Institute for Child Health and Human Development | View source |
| Clindamycin Injection (Package Insert). Schaumberg, IL: APP Pharmaceuticals; 2008 | View source |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Patients Less Than 21 Years of Age (NCT01431326) | Standard of care clindamycin administration |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | There were fewer than 178 participants included in the analysis here. N=104 participants with available data in the Patients Less Than 21 Years of Age (NCT01431326) Arm. BMI was only calculated for children >=2y of age. As such, BMI was calculated for all 22 participants in this study but only 104/178 (58%) of participants in NCT01431326/POP01. | Mean | Standard Deviation | Percentile |
|
|
|
|
| Primary | Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status. | Posted | Median | Full Range | L/h/kg | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
|
|
|
| Primary | Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status. | Posted | Median | Full Range | L/h/70 kg | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
|
|
|
| Primary | PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status. | Posted | Median | Full Range | L | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
|
|
|
| Post-Hoc | Half-life | 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 half-life by age cohort are presented below. Sampling schedule details for PTN_POPS and Staph Trio were comparable. | In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status. | Posted | Median | Full Range | hours | After participant transitioned from IV Clindamycin to oral Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
|
|
|
| Primary | PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. | 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. | In order to determine the impact of obesity and the best weight measure for dosing, only children ≥ 2 years of age were compared (PTN_Clinda obese study n = 21; PTN_POPS study n = 104; and Staph Trio study n = 0). The PK model suggested dosing should be based on Total Body Weight (TBW) regardless of obesity status. | Posted | Median | Full Range | L/kg | After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples). |
|
|
|
| 1 |
| 4 |
| 0 |
| 4 |
| EG001 | Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th) | Clindamycin IV: Children ages 2 to 11 years old with BMI greater than or equal 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 PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care. | 0 | 3 | 0 | 3 |
| EG002 | 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 PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care. | 0 | 4 | 0 | 4 |
| EG003 | Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th) | Clindamycin IV: Children ages 12 to 17 years old with BMI greater than or equal 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 PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care. | 0 | 11 | 2 | 11 |
| EG004 | Patients Less Than 21 Years of Age (NCT01431326) | Standard of care clindamycin administration | 0 | 178 | 0 | 178 |
| Jugular vein thrombosis | Vascular disorders | MedDRA (17.0) |
|
Not provided
Not provided
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D004364 | Pharmaceutical Preparations |