Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Diseases, Infectious
Intervention: Daptomycin (Drug); Standard of Care (SOC) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Cubist Pharmaceuticals Official(s) and/or principal investigator(s): Ellie Hershberger, Study Director, Affiliation: Cubist Pharmaceuticals
Summary
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome: Percentage of Participants With an Overall Therapeutic Response at Test of Cure VisitPharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])
Detailed description:
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
Eligibility
Minimum age: 1 Year.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Medisys Hospital, Bangalore, India
MS Ramaiah, Bangalore, India
MV Hospital and Research Center, Lucknow, India
BYL Nair Hospital, Mumbai, India
Lokmanya Tilak Municipal Medical College, Mumbai, India
KEM Hospital, Pune, India
Ruby Hall Clinic, Pune, India
Hospital Del Nino, Panama, Panama
University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
Children's Hospital Research Center Oakland, Oakland, California 94606, United States
Children's Hospital of Orange County, Orange, California 92868, United States
Rady Children's Hospital - San Diego, San Diego, California 92123, United States
University of South Florida College of Medicine, Tampa, Florida 33606, United States
Emory University, Atlanta, Georgia 30322, United States
University of Chicago, Chicago, Illinois 60637, United States
Children's Hospital of Michigan, Detroit, Michigan 48201, United States
University of Nebraska Medical Center, Omaha, Nebraska 68198, United States
Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901, United States
Montifiore Medical Center, Bronx, New York 10467, United States
SUNY Downstate Medical Center, Brooklyn, New York 11203, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
Children's Hospital Medical Center of Akron, Akron, Ohio 44308, United States
University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States
Toledo Children's Hospital, Toledo, Ohio 43606, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
LeBonheur Children's Medical Center, Memphis, Tennessee 38105, United States
Vanderbilt University Medical Center and Children's Hospital, Nashville, Tennessee 37232, United States
Cook Children's Medical Center, Fort Worth, Texas 76104, United States
Texas Children's Hospital, Houston, Texas 77030, United States
The University of Texas Health Science Center, Houston, Texas 77030, United States
Additional Information
Starting date: July 2008
Last updated: July 14, 2015
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