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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


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 Visit

Pharmacokinetics (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


Minimum age: 1 Year. Maximum age: 17 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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