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Trial record 3 of 231 for:    clindamycin

Safety and Pharmacokinetics of Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (CLIN01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744730
Recruitment Status : Completed
First Posted : December 7, 2012
Results First Posted : October 19, 2016
Last Update Posted : November 29, 2016
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Emmes Company, LLC
Information provided by (Responsible Party):
Phillip Brian Smith, Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Bacterial Infections
Obesity
Intervention Drug: Clindamycin
Enrollment 22
Recruitment Details Eligible participants (inpatients) were recruited in 4 hospitals in the United States. All participants were required to be receiving intravenous (IV) Clindamycin.
Pre-assignment Details 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.
Arm/Group Title Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile) Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th) Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile) Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th) Patients Less Than 21 Years of Age (NCT01431326)
Hide Arm/Group Description 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: 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. 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: 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. Standard of care clindamycin administration.
Period Title: Overall Study
Started 4 3 4 11 178 [1]
Completed 4 3 4 11 178 [1]
Not Completed 0 0 0 0 0
[1]
Please note this study (NCT01431326) is ongoing and data only represents a subset of this study.
Arm/Group Title Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile) Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th) Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile) Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th) Patients Less Than 21 Years of Age (NCT01431326) Total
Hide Arm/Group Description 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: 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. 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: 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. Standard of care clindamycin administration Total of all reporting groups
Overall Number of Baseline Participants 4 3 4 11 178 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 4 participants 11 participants 178 participants 200 participants
<=18 years
4
 100.0%
3
 100.0%
4
 100.0%
11
 100.0%
178
 100.0%
200
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 4 participants 11 participants 178 participants 200 participants
9.4  (2.7) 10.6  (1.4) 14.6  (1.7) 14.8  (1.7) 7.2  (6.9) 7.8  (6.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 4 participants 11 participants 178 participants 200 participants
Female
2
  50.0%
0
   0.0%
1
  25.0%
1
   9.1%
74
  41.6%
78
  39.0%
Male
2
  50.0%
3
 100.0%
3
  75.0%
10
  90.9%
104
  58.4%
122
  61.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 4 participants 11 participants 178 participants 200 participants
Hispanic or Latino
1
  25.0%
0
   0.0%
0
   0.0%
1
   9.1%
52
  29.2%
54
  27.0%
Not Hispanic or Latino
3
  75.0%
2
  66.7%
3
  75.0%
10
  90.9%
124
  69.7%
142
  71.0%
Unknown or Not Reported
0
   0.0%
1
  33.3%
1
  25.0%
0
   0.0%
2
   1.1%
4
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 4 participants 11 participants 178 participants 200 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.1%
2
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
1
   0.5%
Black or African American
0
   0.0%
0
   0.0%
1
  25.0%
1
   9.1%
28
  15.7%
30
  15.0%
White
4
 100.0%
2
  66.7%
2
  50.0%
10
  90.9%
132
  74.2%
150
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.1%
2
   1.0%
Unknown or Not Reported
0
   0.0%
1
  33.3%
1
  25.0%
0
   0.0%
13
   7.3%
15
   7.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 3 participants 4 participants 11 participants 178 participants 200 participants
4 3 4 11 NA [1]  NA [2] 
[1]
NCT01431326 did not collect region of enrollment.
[2]
Total not calculated because data are not available (NA) in one or more arms.
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentile
Number Analyzed 4 participants 3 participants 4 participants 11 participants 178 participants 200 participants
90.5  (3.6) 97.4  (1.2) 91.7  (3.0) 98.3  (1.3) 83.1  (25.9) 85.2  (24.1)
[1]
Measure Description: 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.
1.Primary Outcome
Title Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Hide Description

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.

Time Frame After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clindamycin- Ages >2 to 6 Years Old (Non-Obese) Clindamycin- Ages >2 to 6 Years Old (Obese) Clindamycin- Ages >6 to 12 Years Old (Non-Obese) Clindamycin- Ages >6 to 12 Years Old (Obese) Clindamycin- Age >12 Years Old (Non-Obese) Clindamycin- Age >12 Years Old (Obese)
Hide Arm/Group Description:
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Overall Number of Participants Analyzed 8 12 15 20 26 44
Median (Full Range)
Unit of Measure: L/h
4.2
(0.9 to 9.1)
5.7
(1.8 to 8.3)
12.5
(3.6 to 34.4)
10.7
(4.7 to 26.7)
14.3
(5.6 to 37.4)
19.2
(3.9 to 33.7)
2.Primary Outcome
Title Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Hide Description

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.

Time Frame After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clindamycin- Ages >2 to 6 Years Old (Non-Obese) Clindamycin- Ages >2 to 6 Years Old (Obese) Clindamycin- Ages >6 to 12 Years Old (Non-Obese) Clindamycin- Ages >6 to 12 Years Old (Obese) Clindamycin- Age >12 Years Old (Non-Obese) Clindamycin- Age >12 Years Old (Obese)
Hide Arm/Group Description:
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Overall Number of Participants Analyzed 8 12 15 20 26 44
Median (Full Range)
Unit of Measure: L/h/kg
0.2
(0.1 to 0.8)
0.3
(0.1 to 0.4)
0.3
(0.1 to 0.8)
0.2
(0.1 to 0.6)
0.2
(0.1 to 0.5)
0.2
(0 to 0.7)
3.Primary Outcome
Title Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Hide Description

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.

Time Frame After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clindamycin- Ages >2 to 6 Years Old (Non-Obese) Clindamycin- Ages >2 to 6 Years Old (Obese) Clindamycin- Ages >6 to 12 Years Old (Non-Obese) Clindamycin- Ages >6 to 12 Years Old (Obese) Clindamycin- Age >12 Years Old (Non-Obese) Clindamycin- Age >12 Years Old (Obese)
Hide Arm/Group Description:
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Overall Number of Participants Analyzed 8 12 15 20 26 44
Median (Full Range)
Unit of Measure: L/h/70 kg
10.6
(3.6 to 35)
14.8
(5.5 to 20.3)
20.7
(7.1 to 48.5)
14.7
(5.9 to 39.2)
15.8
(4.7 to 34.7)
14
(3.1 to 37.9)
4.Primary Outcome
Title PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Hide Description

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.

Time Frame After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clindamycin- Ages >2 to 6 Years Old (Non-Obese) Clindamycin- Ages >2 to 6 Years Old (Obese) Clindamycin- Ages >6 to 12 Years Old (Non-Obese) Clindamycin- Ages >6 to 12 Years Old (Obese) Clindamycin- Age >12 Years Old (Non-Obese) Clindamycin- Age >12 Years Old (Obese)
Hide Arm/Group Description:
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Overall Number of Participants Analyzed 8 12 15 20 26 44
Median (Full Range)
Unit of Measure: L
15.3
(7.6 to 19.7)
17.6
(8.4 to 25.2)
29.0
(17.5 to 57.4)
46.9
(32.9 to 85.8)
60.1
(22.5 to 94.6)
85.8
(28.5 to 160.0)
5.Primary Outcome
Title PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Hide Description

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.

Time Frame After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clindamycin- Ages >2 to 6 Years Old (Non-Obese) Clindamycin- Ages >2 to 6 Years Old (Obese) Clindamycin- Ages >6 to 12 Years Old (Non-Obese) Clindamycin- Ages >6 to 12 Years Old (Obese) Clindamycin- Age >12 Years Old (Non-Obese) Clindamycin- Age >12 Years Old (Obese)
Hide Arm/Group Description:
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Overall Number of Participants Analyzed 8 12 15 20 26 44
Median (Full Range)
Unit of Measure: L/kg
0.8
(0.7 to 1.3)
0.9
(0.7 to 1.0)
0.9
(0.7 to 1.1)
1.0
(0.7 to 1.3)
0.9
(0.7 to 1.3)
0.9
(0.6 to 1.6)
6.Post-Hoc Outcome
Title Half-life
Hide Description

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.

Time Frame After participant transitioned from IV Clindamycin to oral Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Clindamycin- Ages >2 to 6 Years Old (Non-Obese) Clindamycin- Ages >2 to 6 Years Old (Obese) Clindamycin- Ages >6 to 12 Years Old (Non-Obese) Clindamycin- Ages >6 to 12 Years Old (Obese) Clindamycin- Age >12 Years Old (Non-Obese) Clindamycin- Age >12 Years Old (Obese)
Hide Arm/Group Description:
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Non-obese patients were those with BMI <85th percentile.
Obese patients were those with BMI greater to or equal to the 85th percentile.
Overall Number of Participants Analyzed 8 12 15 20 26 44
Median (Full Range)
Unit of Measure: hours
2.4
(1.1 to 5.9)
2.2
(1.5 to 4.4)
2.2
(0.9 to 5.8)
3.0
(1.2 to 6.3)
2.8
(1.2 to 7.6)
3.6
(0.9 to 11.3)
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile) Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th) Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile) Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th) Patients Less Than 21 Years of Age (NCT01431326)
Hide Arm/Group Description

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.

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.

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.

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.

Standard of care clindamycin administration
All-Cause Mortality
Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile) Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th) Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile) Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th) Patients Less Than 21 Years of Age (NCT01431326)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile) Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th) Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile) Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th) Patients Less Than 21 Years of Age (NCT01431326)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/3 (0.00%)      0/4 (0.00%)      0/11 (0.00%)      0/178 (0.00%)    
Respiratory, thoracic and mediastinal disorders           
Apnoea  1/4 (25.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 0/11 (0.00%)  0 0/178 (0.00%) 
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile) Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th) Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile) Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th) Patients Less Than 21 Years of Age (NCT01431326)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      2/11 (18.18%)      0/178 (0.00%)    
Skin and subcutaneous tissue disorders           
Rash  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/178 (0.00%) 
Vascular disorders           
Jugular vein thrombosis  0/4 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/11 (9.09%)  1 0/178 (0.00%) 
1
Term from vocabulary, 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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kevin Watt, MD
Organization: Duke Clinical Research Institute, Duke University School of Medicine
Phone: 919-668-8556
EMail: kevin.watt@dm.duke.edu
Other Publications:
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Responsible Party: Phillip Brian Smith, Duke University
ClinicalTrials.gov Identifier: NCT01744730     History of Changes
Other Study ID Numbers: Pro00041855
HHSN275201000003I ( Other Identifier: National Institute of Child Health & Human Development )
First Submitted: December 5, 2012
First Posted: December 7, 2012
Results First Submitted: February 10, 2016
Results First Posted: October 19, 2016
Last Update Posted: November 29, 2016