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Comparative Evaluation of the Safety & Efficacy of Daptomycin Versus SOC in 2 - 17 yr Olds With Staphylococcus Aureus Bacteremia

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: Bacteremia

Intervention: Daptomycin (Drug); Comparator (Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Cubist Pharmaceuticals

Official(s) and/or principal investigator(s):
Erik Deurell, MD, Study Director, Affiliation: Cubist Pharmaceuticals

Overall contact:
Laura Sadowski, Phone: 781-860-8497, Email: laura.sadowski@merck.com

Summary

The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric subjects aged 2-17 years with bacteremia caused by S. aureus.

Clinical Details

Official title: A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects Two - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Assess the safety of i.v. daptomycin versus standard of care antibiotics in pediatric subjects aged 2 - 17 years of age with bacteremia.

Secondary outcome:

Compare the efficacy of i.v. daptomycin versus standard of care antibiotics in pediatric subjects aged 2 - 17 years of age with bacteremia caused by S. aureus.

Determine exposure by measuring plasma levels of daptomycin at pre-dose (trough) and end of infusion (Cmax) to explore exposure-response analyses in pediatric subjects aged 2 - 17 years of age with bacteremia.

Detailed description: Staphylococcus aureus causes a series of invasive diseases in adults and children, including bacteremia. Infections due to S. aureus in children, particularly those due to methicillin resistant S. aureus (MRSA), are a growing world-wide public health concern. Daptomycin, a cyclic lipopeptide antibacterial agent, shows rapid in vitro bactericidal activity with concentration-dependent killing for Gram-positive organisms, including S. aureus. Surveillance studies have demonstrated a daptomycin MIC90 of 0. 5µg/ml for both methicillin-susceptible Staphylococcus aureus (MSSA) and MRSA with >99% of MRSA isolates being categorized as susceptible by the Food and Drug Administration (FDA), European Committee of antimicrobial susceptibility testing (EUCAST) and Clinical and Laboratory Standards Institute (CLSI) breakpoints (5). Clinical trials in adults demonstrated that daptomycin was safe and efficacious in complicated skin and skin structure infections (cSSSI) and bloodstream infections caused by S. aureus, including right-sided infective endocarditis (RIE). However, information on the safety and efficacy of daptomycin for use in children is lacking. The intent of this study in children is to confirm the safety of daptomycin at mean steady state systemic exposures (AUC) similar to those reported for adults treated at 6 mg/kg for bacteremia.

Eligibility

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: To be included in this study, participants must:

- Sign a parental consent form; if appropriate, sign an assent form

- Be between 2 and 17 years of age

- Have proven or probable bacteremia caused by Staphylococcus aureus based on the

traditional culture result, rapid diagnostic test or Gram stain

- If female of childbearing potential, must not be pregnant or nursing and take

appropriate measures to not get pregnant during the study

- If male, must take appropriate measures to not get partner pregnant

- Able to comply with the protocol requirements

Exclusion Criteria: Participants will not be allowed into the study if they:

- Have received a certain amount of antibacterial therapy specific for current

bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;

- Anticipate to require other antibiotics that may be potentially effective against S.

aureus;

- Have shock or hypotension unresponsive to standard therapy;

- Have received an investigational product or have participated in an experimental

procedure within 30 days;

- Have an intolerance or hypersensitivity to daptomycin;

- Have renal insufficiency;

- Have prior history or current evidence of muscle damage (rhabdomyolysis; significant

creatine phosphokinase (CPK) elevation);

- Have history of clinically significant muscular disease, nervous system or seizure

disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;

- Have S. aureus pneumonia, empyema, meningitis, or endocarditis

Locations and Contacts

Laura Sadowski, Phone: 781-860-8497, Email: laura.sadowski@merck.com

Buenos Aires, Argentina; Recruiting
Eduardo Lopez, Principal Investigator

Buenos Aires, Argentina; Recruiting
Eduardo Teplitz, MD, Principal Investigator

Santa Fe 3000, Argentina; Recruiting
Gustavo Cesar Ezcurra, Principal Investigator

Clayton, Victoria, Australia; Recruiting
Jim Butttery, MD, Principal Investigator

Garran, Australia; Recruiting
Graham Reynolds, MD, Principal Investigator

Geelong, Australia; Recruiting
Eugene Athan, MD, Principal Investigator

Parkville, Victoria, Australia; Withdrawn

Belo Horizonte/Minas Gerias, Brazil; Recruiting
Antonio Tarcisio Faria Freire, MD, Principal Investigator

Curitiba, Brazil; Recruiting
Fabio Araujo Motta, MD, Principal Investigator

Sao Paulo, Brazil; Recruiting

São José do Rio Preto - sp, Brazil; Recruiting
Marcia Catelan, MD, Principal Investigator

Concepcion, Chile; Not yet recruiting

Puente Alto, Chile; Recruiting
Carmen Sandoval, MD, Principal Investigator

Santiago, Chile; Withdrawn

Bogota, Colombia; Not yet recruiting
Jaime Cespedes, MD, Principal Investigator

Cali, Colombia; Not yet recruiting
Pio Lopez, MD, Principal Investigator

Medellin, Colombia; Recruiting
Monica Tujillo, MD, Principal Investigator

Athens 11527, Greece; Recruiting
Nikos Spyridis, Principal Investigator

Athens, Greece; Recruiting
Athanasios Michos, MD, Principal Investigator

Thessaloniki 54642, Greece; Recruiting
Emmanuel Roilides, Principal Investigator

Guatemala, Guatemala; Not yet recruiting

Budapest 1086, Hungary; Recruiting
Gariella Kiss, Principal Investigator

Debrecen 4012, Hungary; Recruiting
Edit Szikszay, MD, Principal Investigator

Miskolc 3526, Hungary; Recruiting
Aranka Bolyos, Principal Investigator

Hadera, Israel; Recruiting
Adi Klein-Kramer, MD, Principal Investigator

Holon, Israel; Recruiting
Eli Somekh, MD, Principal Investigator

Jerusalem, Israel; Recruiting
Dan Engelhard, MD, Principal Investigator

Milano, Italy; Recruiting
Susanna Esposito, Principal Investigator

Rome 00165, Italy; Recruiting
Patrizia D'Argenio, Principal Investigator

Turin, Italy; Recruiting
Pier-Angelo Tovo, Principal Investigator

Kota Bharu/ Kelantan 16150, Malaysia; Recruiting
Azlan Bin Husin, Principal Investigator

Kuching / Sarawak 93586, Malaysia; Recruiting
Hock Hin Chua, Principal Investigator

Panama 0843-0167, Panama; Recruiting
Kathia Luciani, Principal Investigator

Panama, Panama; Withdrawn

Panama, Panama; Recruiting
Dora Estripeaut, Principal Investigator

Brasov 500063, Romania; Recruiting
Oana Falup-Pecurariu, Principal Investigator

Cluj-Napoca, Romania; Recruiting
Horatiu Gocan, Principal Investigator

Timisoara, Romania; Recruiting
Eugen-Sorin Boia, Principal Investigator

Castello 12070, Spain; Recruiting
Antonio Perez Iranzo, Principal Investigator

Esplugues 8950, Spain; Recruiting
Antoni Noguera-Julian, Principal Investigator

Madrid, Spain; Recruiting
Pablo Rojo, Principal Investigator

Valencia, Spain; Recruiting
Maria Carmen Otero, Principal Investigator

Taipei, Taiwan; Recruiting
Li-Min Huang, Principal Investigator

Bangkok 10700, Thailand; Recruiting
Wanatpreeya Phongsamart, Principal Investigator

Bangkok, Thailand; Recruiting
Veerachai Watanaveeradej, Principal Investigator

Khon Kaen 40002, Thailand; Recruiting
Pope Kosalaraksa, Principal Investigator

Pathum thanee, Thailand; Recruiting
Auchara Tangsathapornpong, Principal Investigator

Dnipropetrovsk, Ukraine; Recruiting
Valery Digtyar, MD, Principal Investigator

Kharkiv, Ukraine; Recruiting
Ganna Senatorova, MD, Principal Investigator

Kirovograd, Ukraine; Recruiting
Volodymyr Bilyy, MD, Principal Investigator

Kyiv, Ukraine; Recruiting
Natalia Karpenko, Principal Investigator

Lugansk, Ukraine; Withdrawn

Vinnitsa, Ukraine; Recruiting
Dmytro Dmytriiev, MD, Principal Investigator

Zaporizhzhia, Ukraine; Recruiting
Andriy Chalov, Principal Investigator

Arizona Children's Center at Maricopa Medical Center, Phoenix, Arizona 85006, United States; Recruiting
Amin Ostovar, Principal Investigator

Children's Hospital of Orange County, Orange, California 92868, United States; Recruiting
Antonio Arrieta, MD, Principal Investigator

Rady Children's Hospital, San Diego, California 92123, United States; Recruiting
John Bradley, MD, Principal Investigator

Nemours/Al duPont Hospital for Children, Wilmington, Delaware 19803, United States; Completed

Getafe, Madrid 28905, Spain; Recruiting
Jose Ramos, Principal Investigator

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Diana Florescu, MD, Principal Investigator

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States; Recruiting
Kari Simonsen, MD, Principal Investigator

Montefiore Medical Center, Bronx, New York 10467, United States; Withdrawn

Akron Children's Hospital, Akron, Ohio 44308, United States; Withdrawn

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States; Recruiting
Aurelia Balan, MD, Principal Investigator

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania 15224, United States; Recruiting
Marian Michaels, MD, MPH, Principal Investigator

Gueishan Township, Taoyuan County, Taiwan; Not yet recruiting
Chen-Hsun Chiu, Principal Investigator

LeBonheur Children's Hospital, Memphis, Tennessee 38103, United States; Completed

Texas Tech University Health Sciences Center, Amarillo, Texas 79106, United States; Recruiting
Tetyana Vasylyeva, Principal Investigator

Cook Children's Medical Center, Fort Worth, Texas 76104, United States; Recruiting
Lynne Eger, MD, Principal Investigator

University of Texas Health Sciences Center, Houston, Texas 77030, United States; Recruiting
Gloria Heresi, MD, Principal Investigator

Additional Information

Starting date: December 2012
Last updated: June 24, 2015

Page last updated: August 23, 2015

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