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

Completed · Phase 4

Conditions studied: Skin Diseases, Infectious

In brief

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.

Key facts

Study ID

NCT00711802

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

396

Starts

2008-07-23

Expected to finish

2013-10-11

Last updated by the study team

2018-09-05

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Children's Hospital Research Center Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
• SUNY Downstate Medical Center — Brooklyn, New York, United States
• Montifiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital Medical Center of Akron — Akron, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Toledo Children's Hospital — Toledo, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• LeBonheur Children's Medical Center — Memphis, Tennessee, United States
• Vanderbilt University Medical Center and Children's Hospital — Nashville, Tennessee, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• The University of Texas Health Science Center — Houston, Texas, United States
• Medisys Hospital — Bangalore, India
• MS Ramaiah — Bangalore, India
• MV Hospital and Research Center — Lucknow, India

Full record on ClinicalTrials.gov

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