This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess
the safety, efficacy and pharmacokinetics of daptomycin in pediatric subjects ages 7-17
years, inclusive, with cSSSI caused by Gram-positive pathogens.
Inclusion Criteria:
- Written parental (or appropriate legal representative) informed consent prior to any
study-related procedure not part of normal medical care;
- Written subject assent (as appropriate);
- Male or female between the ages of 7 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 intravenous antibiotic treatment.
Complicated infections are defined as infections either involving deep soft tissue or
requiring significant surgical intervention (e. g. infected ulcers, burns, and major
abscesses) or infections in which the subject 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 C (99. 5 degrees F) oral
or >38 degrees C (100. 4 degrees F) rectal; white blood count (WBC) >12,000/mm3 or
≥10% bands; swelling and/or induration;erythema (>1 cm beyond edge of wound or
abscess); 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 duration administered
anytime during the 48 hours prior to the first dose of study drug (exception: a
subject 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 subject enrolled in the study that is subsequently
found to have a blood culture positive for bacteremia may be continued as described
in section 10. 4.4);
- Subjects with current or known clinically significant abnormal laboratory test
results (including ECGs) that would expose the subject 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: HIV
infected subjects 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 or
spinal cord injury;
- Administration of intramuscular injection between baseline and study drug
administration or expected intramuscular injection through TOC/Safety visit;
- Suspected or known renal insufficiency;
- History of or current rhabdomyolysis;
- History of (within one year prior to first dose of study drug) or current myositis;
- Current septic shock;
- Known or suspected CPK elevation
Ruby Hall Clinic, Pune, India; Recruiting
B.S. Ratta, MD, Principal Investigator
KEM Hospital, Pune, India; Recruiting
Madhumati Otiv, MD, Principal Investigator
Lokmanya Tilak Municipal Medical College, Mumbai, India; Not yet recruiting
Paras Kothari, MD, Principal Investigator
BYL Nair Hospital, Mumbai, India; Recruiting
Rachita Dhurat, MD, Principal Investigator
Medisys Hospital, Bangalore, India; Recruiting
D.N. Balraj, MD, Principal Investigator
Citi Hospital, Bangalore, India; Recruiting
S Sacchidanand, MD, Principal Investigator
MS Ramaiah, Bangalore, India; Recruiting
T.K. Sumathy, MD, Principal Investigator
MV Hospital and Research Center, Lucknow, India; Recruiting
Rajeev Agarwal, MD, Principal Investigator
JOSHA Research, Bloemfontein, South Africa; Recruiting
J J Lombaard, MD, Principal Investigator
GCT-Mercantile Clinical Trial Centre, Port Elizabeth, South Africa; Recruiting
Mashra Gani, MD, Principal Investigator
Global Clinical Trials (Pty) Ltd, Temba, South Africa; Recruiting
Andre Bester, MD, Principal Investigator
Middleburg Hospital, Middleburg, South Africa; Recruiting
Peter Matthrews, MD, Principal Investigator
Clinical Projects Research SA (Pty) Ltd, Worcester, South Africa; Not yet recruiting
Christo van Dyk, Principal Investigator
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States; Recruiting
David Kimberlin, MD, Principal Investigator
Rady Children's Hospital - San Diego, San Diego, California 92123, United States; Recruiting
John Bradley, MD, Principal Investigator
Miller Children's Hospital, Long Beach, California 90806, United States; Recruiting
David Lang, MD, Principal Investigator
Children's Hospital of Orange County, Orange, California 92868, United States; Recruiting
Antonio Arreita, MD, Principal Investigator
Children's Hospital Reseach Center Oakland, Oakland, California 94606, United States; Recruiting
Brian Lee, MD, Principal Investigator
The Children's Hospital, Aurora, Colorado 80045, United States; Not yet recruiting
Eric A. F. Simões, MD, Principal Investigator
Lee Memorial Health System, Fort Myers, Florida 33908, United States; Recruiting
Robin Churchill, MD, Principal Investigator
University of South Florida College of Medicine, Tampa, Florida 33606, United States; Recruiting
Lisa Rodriguez, MD, Principal Investigator
Emory University, Atlanta, Georgia 30322, United States; Not yet recruiting
Allison Ross, MD, Principal Investigator
University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Robert Daum, MD, Principal Investigator
University of Louisiana at Monroe, Shreveport, Louisiana 71103, United States; Recruiting
Ronda Akins, RPh, Principal Investigator
Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting
Ellen Cooper, MD, Principal Investigator
Children's Hospital of Michigan, Detroit, Michigan 48201, United States; Recruiting
Nahed Abdel-Haq, MD, Principal Investigator
Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Christopher Harrison, MD, Principal Investigator
University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Kari Simonsen, MD, Principal Investigator
Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901, United States; Recruiting
Amisha Malhotra, MD, Principal Investigator
Montifiore Medical Center, Bronx, New York 10467, United States; Recruiting
Tsoline Kojaoghlanian, MD, Principal Investigator
SUNY Downstate Medical Center, Brooklyn, New York 11203, United States; Not yet recruiting
Margaret Hammerschlag, MD, Principal Investigator
Duke University Medical Center, Durham, North Carolina 27710, United States; Recruiting
Coleen Cunningham, MD, Principal Investigator
Nationwide Children's Hospital, Columbus, Ohio 43205, United States; Withdrawn
University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting
Jeffrey Blumer, MD, Principal Investigator
Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States; Recruiting
Blaise Congeni, MD, Principal Investigator
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Susana Chavez-Bueno, MD, Principal Investigator
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Withdrawn
LeBonheur Children's Medical Center, Memphis, Tennessee 38105, United States; Recruiting
Keith English, MD, Principal Investigator
Vanderbuilt University Medical Center and Children's Hospital, Nashville, Tennessee 37232, United States; Recruiting
Clarence Creech, MD, Principal Investigator
Texas Children's Hospital, Houston, Texas 77030, United States; Recruiting
Sheldon Kaplan, MD, Principal Investigator
Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Recruiting
Lynne Eger, MD, Principal Investigator
The University of Texas Health Science Center, Houston, Texas 77030, United States; Recruiting
Gloria Heresi, MD, Principal Investigator
