Bacterial InfectionsPhase 1CLIN01NCT01744730

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

A Phase 1 study testing Clindamycin in people with Bacterial Infections and Obesity, run by Phillip Brian Smith at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Bacterial Infections, Obesity
What is being tested?: Clindamycin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 4 sitesUnited States
Study dates: Jun 2013to Aug 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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)

Who cannot join

The following apply only to those who are NOT already receiving clindamycin per routine care:
History of hypersensitivity or allergic reaction to clindamycin or lincomycin
History of C. difficile colitis with previous administration of clindamycin
Aspartate aminotransferase (AST) > 120 units/L
Alanine aminotransferase (ALT) > 210 units/L
Total bilirubin > 3 mg/dL

Show all 14Show fewer

Serum creatinine > 2 mg/dL
Receiving a neuromuscular blocker as part of their therapy
Previous participation in the study
Subject is on prohibited medication or herbal product (see Appendix II)
Subject is receiving extracorporeal life support (ECLS)
Subject is post-cardiac bypass (within 24 hours)
Subject on inotropes/pressors
Any other condition or chronic illness that, in the opinion of the principal investigator, makes participation unadvised or unsafe

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Akron Children's Hospital
Akron, Ohio, 48109
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Children's Mercy Hospital
Kansas City, Kansas, 64108
University of Louisville
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (NICHD): CLIN01

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.

Read the detailed description

This is a prospective, open-label pharmacokinetic and safety study of multiple doses of IV and oral clindamycin in overweight and obese children 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).

Conditions: Bacterial Infections, Obesity
Being tested: Clindamycin
Keywords: Bacterial infections, Obesity, pharmacokinetics, clindamycin
Medical subject headings: Bacterial Infections, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClindamycinDrug
Also called Clindamycin phosphate (intravenous), Clindamycin hydrochloride (oral capsules), Clindamycin palmitate (oral solution)
Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.

Study groups in NCT01744730
Study group	Role	What they receive
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. Receives: Drug: Clindamycin
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. Receives: Drug: Clindamycin
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. Receives: Drug: Clindamycin
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. Receives: Drug: Clindamycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
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.
Measured: 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.
Measured: 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.
Measured: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Aug 2014

First posted7 Dec 2012 (estimated)
Study startJun 2013
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (27)Papers the sponsor has linked to this study.
Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01744730
Sponsor's protocol ID: Pro00041855
Other IDs: HHSN275201000003I
Acronym: CLIN01
Status last verified: Oct 2016
First submitted: 5 Dec 2012
Last updated: 29 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 19463065
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.
PubMed 20478934
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.
PubMed 22253364
Kasten MJ. Clindamycin, metronidazole, and chloramphenicol. Mayo Clin Proc. 1999 Aug;74(8):825-33. doi: 10.4065/74.8.825.
PubMed 10473362
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.
PubMed 17655508
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.
PubMed 10843460
Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006 Jul;6(7):438-46. doi: 10.1016/S1473-3099(06)70523-0.
PubMed 16790384
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.
PubMed 22477819
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.
PubMed 12839703
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.
PubMed 20975453
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.
PubMed 6470871
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.
PubMed 3737273
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.
PubMed 4480976
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.
PubMed 4488654
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.
PubMed 18623043

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections

All Bacterial Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects With BMI ≥ 85th Percentile (NICHD): CLIN01
ClinicalTrials.gov ID: NCT01744730
Acronym / sponsor ID: CLIN01 / Pro00041855
Conditions: Bacterial Infections, Obesity
Keywords: Bacterial infections, Obesity, pharmacokinetics, clindamycin
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Phillip Brian SmithUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), The Emmes Company, LLC
Study start: Jun 2013
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 7 Dec 2012 (estimated)
Results: Posted 19 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)	Active comparator	Drug: ClindamycinClindamycin 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	Drug: ClindamycinClindamycin 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	Drug: ClindamycinClindamycin 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	Drug: ClindamycinClindamycin 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.

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (14 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClindamycinAlso: Clindamycin phosphate (intravenous), Clindamycin hydrochloride (oral capsules), Clindamycin palmitate (oral solution)Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.	Drug	Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th), 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)

Primary outcome

Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis. PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of empirical Bayesian Estimates (EBE) for clearance by age cohort are presented below. Sampling schedule details for PTN_POPS and Staph Trio were comparable.
Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis. PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 1 kg of body weight are presented below. Sampling schedule details for PTN_POPS and Staph Trio were comparable.
Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis. PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for clearance by age cohort normalized to 70 kg of body weight are presented below. Sampling schedule details for PTN_POPS and Staph Trio were comparable.
PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese and non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis. PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort are presented below. Sampling schedule details for PTN_POPS and Staph Trio were comparable.
PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.
Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).
In order to understand the impact of obesity on clindamycin PK, PK data were combined to build a PK model from 3 studies that included both obese \& non-obese children: 1) PTN_Clinda Obese study (clinicaltrials.gov/ct.gov identifier NCT01744730) n = 21; 2) PTN_POPS study (ct.gov identifier NCT01431326) n = 178; and 3) Staph Trio study (ct.gov identifier NCT01728363) n = 21. The data from the Staph-Trio study were only included for PK modeling and not intended to be compared in the analysis. PK sampling schedule for PTN_Clinda Obese was: Pre-dose 0 (within 15 minutes prior to IV clindamycin dose), 0.5 (± 5 minutes) after dose was administered, 1-1.5 hours (hrs) after dose, 3-4 hrs after, 5-6 hrs after, and pre-next dose. Samples were collected on multiple days and averaged to arrive at a single value. Comparison of EBE for volume of distribution by age cohort normalized to 1kg of body weight are presented below. Sampling schedule details for PTN_POPS \& Staph Trio were comparable.

Results and safety

Results posted to the registry on 19 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)	4	4
Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)	3	3
Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)	4	4
Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)	11	11
Patients Less Than 21 Years of Age (NCT01431326)	178	178

Primary outcome: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.

Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).. Median (Full Range). Unit: L/h

Measure	Clindamycin- Ages >2 to 6 Years Old (Non-Obese) n = 8	Clindamycin- Ages >2 to 6 Years Old (Obese) n = 12	Clindamycin- Ages >6 to 12 Years Old (Non-Obese) n = 15	Clindamycin- Ages >6 to 12 Years Old (Obese) n = 20	Clindamycin- Age >12 Years Old (Non-Obese) n = 26	Clindamycin- Age >12 Years Old (Obese) n = 44
Value	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)

Population analysed: 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.

Primary outcome: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.

Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).. Median (Full Range). Unit: L/h/kg

Measure	Clindamycin- Ages >2 to 6 Years Old (Non-Obese) n = 8	Clindamycin- Ages >2 to 6 Years Old (Obese) n = 12	Clindamycin- Ages >6 to 12 Years Old (Non-Obese) n = 15	Clindamycin- Ages >6 to 12 Years Old (Obese) n = 20	Clindamycin- Age >12 Years Old (Non-Obese) n = 26	Clindamycin- Age >12 Years Old (Obese) n = 44
Value	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)

Primary outcome: Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.

Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).. Median (Full Range). Unit: L/h/70 kg

Measure	Clindamycin- Ages >2 to 6 Years Old (Non-Obese) n = 8	Clindamycin- Ages >2 to 6 Years Old (Obese) n = 12	Clindamycin- Ages >6 to 12 Years Old (Non-Obese) n = 15	Clindamycin- Ages >6 to 12 Years Old (Obese) n = 20	Clindamycin- Age >12 Years Old (Non-Obese) n = 26	Clindamycin- Age >12 Years Old (Obese) n = 44
Value	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)

Primary outcome: PK - Volume of Distribution (V) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin.

Time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6 samples).. Median (Full Range). Unit: L

Measure	Clindamycin- Ages >2 to 6 Years Old (Non-Obese) n = 8	Clindamycin- Ages >2 to 6 Years Old (Obese) n = 12	Clindamycin- Ages >6 to 12 Years Old (Non-Obese) n = 15	Clindamycin- Ages >6 to 12 Years Old (Obese) n = 20	Clindamycin- Age >12 Years Old (Non-Obese) n = 26	Clindamycin- Age >12 Years Old (Obese) n = 44
Value	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)

Adverse events

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile)	1 of 4 (25%)	0 of 4 (0%)	Not reported
Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th)	0 of 3 (0%)	0 of 3 (0%)	Not reported
Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile)	0 of 4 (0%)	0 of 4 (0%)	Not reported
Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th)	0 of 11 (0%)	2 of 11 (18.2%)	Not reported
Patients Less Than 21 Years of Age (NCT01431326)	0 of 178 (0%)	0 of 178 (0%)	Not reported

Limitations and caveats (from the sponsor): Data from 3 different studies was included to increase the robustness of the population PK model developed and leverage all available clindamycin PK data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19463065Gerber 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.
Background: PubMed 20478934Herigon 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.
Background: PubMed 22253364Ogden 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.
Background: PubMed 10473362Kasten MJ. Clindamycin, metronidazole, and chloramphenicol. Mayo Clin Proc. 1999 Aug;74(8):825-33. doi: 10.4065/74.8.825.
Background: PubMed 17655508Pai MP, Bearden DT. Antimicrobial dosing considerations in obese adult patients. Pharmacotherapy. 2007 Aug;27(8):1081-91. doi: 10.1592/phco.27.8.1081.
Background: PubMed 10843460Bearden 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.
Background: PubMed 16790384Falagas ME, Kompoti M. Obesity and infection. Lancet Infect Dis. 2006 Jul;6(7):438-46. doi: 10.1016/S1473-3099(06)70523-0.
Background: PubMed 22477819Reed 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.
Background: PubMed 12839703Jacobs 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.
Background: PubMed 20975453Bradley 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.
Background: PubMed 6470871Bell 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.
Background: PubMed 3737273Koren 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.
Pediatric Trials NetworkLink provided by the sponsor.
National Institute for Child Health and Human DevelopmentLink provided by the sponsor.
Clindamycin Injection (Package Insert). Schaumberg, IL: APP Pharmaceuticals; 2008Link provided by the sponsor.

Related trials for Bacterial Infections

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

P. Brian Smith, MD, MHS, MPH principal investigator

Duke Medical Center/Duke Clinical Research Institute

Kevin Watt, MD principal investigator

Duke Medical Center/Duke Clinical Research Institute

Michael J Smith, MD principal investigator

University of Louisville

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Clindamycin in people with Bacterial Infections and Obesity, run by Phillip Brian Smith at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK) - Clearance (Cl) in Participants Who Received Multiple Doses of Intravenous (IV) Clindamycin. (time frame: After first study dose of IV Clindamycin through Day 14 (minimum of 3 samples; maximum of 6).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01744730, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.