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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01744730
Registration number
NCT01744730
Ethics application status
Date submitted
5/12/2012
Date registered
7/12/2012
Date last updated
29/11/2016
Titles & IDs
Public title
Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI = 85th Percentile
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Scientific title
Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI = 85th Percentile (NICHD): CLIN01
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Secondary ID [1]
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HHSN275201000003I
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Secondary ID [2]
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Pro00041855
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Universal Trial Number (UTN)
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Trial acronym
CLIN01
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bacterial Infections
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0
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Obesity
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Clindamycin
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.
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.
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.
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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) sub-score change from baseline.
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Assessment method [1]
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The KOOS ADL will be measured before surgery and at a minimum 1 year after surgery. The KOOS is a patient self-administered questionnaire that consists of 42 questions. The KOOS consists of 5 subscales; pain, other symptoms, activities of daily living (ADL), sport and recreational function and knee-related quality of life. Each question has 5 Likert-like response options. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The change from baseline is the minimum 1 year (approximately 304 to 668 days) measurement minus the baseline measurement.
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Timepoint [1]
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One year or later (approximately 304 days or later)
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Primary outcome [2]
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Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
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Assessment method [2]
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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.
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Timepoint [2]
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After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).
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Primary outcome [3]
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Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
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Assessment method [3]
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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.
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Timepoint [3]
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0
After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
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Primary outcome [4]
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Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
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Assessment method [4]
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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.
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Timepoint [4]
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After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
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Primary outcome [5]
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PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
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Assessment method [5]
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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.
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Timepoint [5]
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After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
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Primary outcome [6]
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PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
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Assessment method [6]
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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.
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Timepoint [6]
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After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
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Secondary outcome [1]
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Patient Reported Outcome: Oxford Knee Score (OKS)
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Assessment method [1]
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The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having 5 Likert- like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OKS measures pain and general activities of daily living.
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Timepoint [1]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [2]
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Patient Reported Outcome: Pre-surgical/Post-surgical Patient's Knee Implant Performance (PKIP)
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Assessment method [2]
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The Pre Surgical and/or Post-surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
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Timepoint [2]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [3]
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Patient Report Outcome: EuroQol 5D 3L questionnaire (EQ-5D-3L)
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Assessment method [3]
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EuroQol 5D 3L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject.
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Timepoint [3]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [4]
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Type and Frequency of Adverse Events (AEs) for all enrolled subjects
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Assessment method [4]
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All Serious AEs must be reported to Sponsor. All device-related or procedure-related adverse events must be reported to Sponsor.
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Timepoint [4]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [5]
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Evaluate primary cemented fixation through zonal radiographic analysis post-operatively
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Assessment method [5]
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Radiographs will be reviewed by an independent radiographic reviewer (IRR). Data from the IRR radiographic evaluations will be used for determination of radiographic success criteria.
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Timepoint [5]
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minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [6]
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Incidence of post-operative anterior knee pain and symptomatic/asymptomatic crepitus
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Assessment method [6]
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The Anterior Knee Pain and Crepitus questionnaire will be used. It is a 2 part questionnaire that is patient-self administered. The crepitus questions include frequency of crepitus and whether or not crepitus is symptomatic. The anterior knee pain contains 2 questions that collect frequency of pain and location of pain.
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Timepoint [6]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [7]
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Evaluate surgeon learning curve on clinical and functional outcomes
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Assessment method [7]
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Each surgeon will implant devices into the first 10 Subjects which will be considered as 'learning curve cases'; these learning curve cases will not be pooled with post-learning curve cases unless learning curve analyses indicate that there is not a significant learning curve with regard to clinical or functional Subject outcomes.
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Timepoint [7]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [8]
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Evaluate the impact of ligament balancing surgical technique on functional performance
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Assessment method [8]
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Description of the Subject's surgical procedure including such items as surgical approach and ligament balancing will be evaluated.
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Timepoint [8]
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Operatively (Day 0 - Date of Surgery)
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Secondary outcome [9]
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Psychometric Properties of the Patient Knee Implant Performance (PKIP)questionnaire
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Assessment method [9]
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The Pre and Post-Surgical Patient's Knee Implant Performance (PKIP) questionnaire is a patient self-administered questionnaire that consists of 25 questions relating to the patient's awareness of their knee. Questions include the patient's self-confidence about the current status of their knee performance, stability, and overall satisfaction. Each question has a 5, 6 or 10 Likert- like response option.
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Timepoint [9]
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Pre-op (-90 to -1 days before surgery), < 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [10]
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Evaluate the functional outcome of patella resurfacing and non-resurfacing
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Assessment method [10]
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An exploratory comparison of results between knees with patella resurfacing versus knees without resurfacing will be conducted. A comparison of KOOS, PKIP, OKS, Knee Society (AKS), anterior knee pain incidence, and crepitus will be conducted.
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Timepoint [10]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Secondary outcome [11]
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Evaluate changes in femoral component and tibial component alignment
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Assessment method [11]
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Radiographs will be reviewed by an independent radiographic reviewer (IRR) in order to minimize bias of radiographic outcomes. Data from the IRR radiographic evaluations will be used to evaluate femoral and tibial component alignment over time.
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Timepoint [11]
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< 1 year (1 to 303 days), minimum 1 year (304 to 668 days), minimum 2 year (669 to 1763 days)
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Eligibility
Key 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)
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Minimum age
2
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Other
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2014
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Sample size
Target
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Illinois
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Kansas
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Kentucky
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Ohio
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Country [5]
0
0
United States of America
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State/province [5]
0
0
California
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Colorado
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Nevada
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Country [8]
0
0
United States of America
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State/province [8]
0
0
New Hampshire
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Funding & Sponsors
Primary sponsor type
Other
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Name
Phillip Brian Smith
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Address
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Country
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Other collaborator category [1]
0
0
Government body
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Name [1]
0
0
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
0
0
Commercial sector/industry
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Name [2]
0
0
The Emmes Company, LLC
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Address [2]
0
0
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Country [2]
0
0
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT01744730
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Trial related presentations / publications
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. 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. 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. Kasten MJ. Clindamycin, metronidazole, and chloramphenicol. Mayo Clin Proc. 1999 Aug;74(8):825-33. doi: 10.4065/74.8.825. 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. 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. Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006 Jul;6(7):438-46. doi: 10.1016/S1473-3099(06)70523-0. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
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This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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P. Brian Smith, MD, MHS, MPH
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Duke Medical Center/Duke Clinical Research Institute
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Gonzalez D, Melloni C, Yogev R, Poindexter BB, Men...
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Gatti G, Flaherty J, Bubp J, White J, Borin M, Gam...
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Results are available at
https://clinicaltrials.gov/study/NCT01744730
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