Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections



Status:Completed
Conditions:Skin and Soft Tissue Infections, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:1 - 17
Updated:9/7/2018
Start Date:July 23, 2008
End Date:October 11, 2013

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An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens

This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess
the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to
17 years, inclusive, with complicated skin and skin structure infections (cSSSI) caused by
Gram-positive pathogens.

This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess
the safety, efficacy, and PK of daptomycin in pediatric participants ages 1 to 17 years,
inclusive, with cSSSI caused by Gram-positive pathogens. Participants will be enrolled into
age groups and given age-dependent doses over a period of up to 14 days. Participants will be
stratified by age group to receive either daptomycin or SOC (recommended as vancomycin,
clindamycin or semisynthetic penicillin) in a ratio of 2:1, respectively. Participants may
continue on oral therapy following completion of IV study drug administration and provided
that the participant meets all criteria for conversion to oral therapy, including clear
clinical improvement and availability of an oral agent to which the pathogen is susceptible.
The choice of oral therapy will be left to the discretion of the Investigator. February 11,
2015 released from post marketing requirement to include subjects aged 3 months - < 1 year.
Ref ID: 3701325

Inclusion Criteria:

- Written parental (or appropriate legal representative) informed consent prior to any
study-related procedure not part of normal medical care

- Written participant assent (as appropriate)

- Male or female between the ages of 1 and 17 years old, inclusive

- If female of childbearing potential (defined as post-menarche), not lactating or
pregnant, documented negative pregnancy test result within 48 hours prior to study
medication administration and willing to practice reliable birth control measures (at
the discretion of the Principal Investigator) during study treatment and for at least
28 days after study completion

- Able to comply with the protocol for the duration of the study

- Skin and skin structure infections of a complicated nature known or suspected to be
caused by Gram-positive pathogen(s) that require IV antibiotic treatment. Complicated
infections are defined as infections either involving deep soft tissue or requiring
significant surgical intervention (such as, infected ulcers, burns, and major
abscesses) or infections in which the participant has a significant underlying disease
state that complicates the response to treatment. The Investigator may contact the
Medical Monitor to discuss infections not meeting this definition but which otherwise
appear appropriate for inclusion

- At least three of the following clinical signs and symptoms associated with the cSSSI:
pain; tenderness to palpation; temperature >37.5 degrees Celsius (C) (99.5 degrees
Fahrenheit [F]) oral or >38 degrees C (100.4 degrees F) rectal; white blood count
(WBC) >12,000/cubic millimeter (mm^3) or ≥10% bands; swelling and/or induration;
erythema (>1 centimeter [cm] beyond edge of wound or abscess); or pus formation

Exclusion Criteria:

- Investigational drug use (including daptomycin) or participation in any experimental
procedure in the 30 days preceding study entry

- Known allergy/hypersensitivity to daptomycin

- Known infection caused solely by Gram-negative pathogen(s), fungus(i), or virus(es)

- Previous systemic antimicrobial therapy exceeding 24 hours in duration administered
anytime during the 48 hours prior to the first dose of study drug (exception: a
participant is eligible if on previous antibiotics without any clinical improvement
and/or a wound culture is available and the pathogen is not sensitive to prior
therapy)

- Known or suspected pneumonia, osteomyelitis, meningitis, or endocarditis

- Known bacteremia (exception: any participant enrolled in the study that is
subsequently found to have a blood culture positive for bacteremia may be continued)

- Participant with current or known clinically significant abnormal laboratory test
results (including electrocardiograms [ECGs]) that would expose the participant to
unacceptable risk as determined by Investigator

- History of clinically significant cardiovascular, renal, hepatic, pulmonary
(well-controlled asthma is acceptable), gastrointestinal, endocrine, hematological,
autoimmune disease, or primary immune deficiency (unless the Investigator considers
that the subject would not be at risk by participating in the study [Note: human
immunodeficiency virus-infected participants must not be enrolled])

- History of or current clinically significant (at the discretion of the Investigator)
muscular disease, nervous system, or seizure disorder

- Unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre
syndrome or spinal cord injury

- Known or suspected renal insufficiency (that is, estimated creatinine clearance rate
[CLcr]<80 mL/min/1.73 squared meter [m^2]

- History of or current rhabdomyolysis

- History of (within 1 year prior to first dose of study drug) or current myositis

- Current septic shock

- Known or suspected creatine phosphokinase (CPK) elevation
We found this trial at
23
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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Tampa, FL
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Akron, OH
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Bangalore, 560001
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Bronx, New York 10467
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Memphis, Tennessee 38105
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New Brunswick, New Jersey 08901
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Toledo, Ohio 43606
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