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Bacteremia |

Bacteremia research study

What is the primary objective of this study?

The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by Staphylococcus aureus (S. aureus).

Who is eligible to participate?

Inclusion Criteria: To be included in this study, participants must: - Sign a parental consent form; if appropriate, sign an assent form - Be between 1 and 17 years of age - Have proven or probable bacteremia caused by S. 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 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bacteremia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DaptomycinIntravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.

Drug:ComparatorVancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Daptomycin - 12 to 17 year oldsParticipants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously (IV), over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).

Comparator - 12 to 17 year oldsParticipants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.

Daptomycin - 7 to 11 year oldsParticipants ages 7 to 11 years old were administered daptomycin 9 mg/kg, infused once daily, IV over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).

Daptomycin - 1 to 6 year oldsParticipants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, IV over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).

Comparator - 7 to 11 year oldsParticipants ages 7-11 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.

Comparator - 1 to 6 year oldsParticipants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.

Study Status

Completed

Start Date: November 2012

Completed Date: January 2016

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Number of Participants With One or More Adverse Events (AEs)

Secondary Outcome: Percentage of Participants With Clinical Success at TOC/Safety Visit

Study sponsors, principal investigator, and references

Principal Investigator: Medical Director

Lead Sponsor: Cubist Pharmaceuticals LLC

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01728376

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