The purpose of this study is to assess the safety, efficacy and pharmacokinetic (PK) parameters of daptomycin for injection in Japanese pediatric participants aged 1 to 17 years with complicated skin and soft tissue infection (cSSTI) or bacteremia caused by gram-positive cocci.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.
Japan Community Health Care Organization Chukyo Hospital ( Site 0030)
Nagoya, Aichi-ken, Japan
Japan Community Health care Organization Kyushu Hospital ( Site 0016)
Kitakyushu, Fukuoka, Japan
Maebashi Red Cross Hospital ( Site 0012)
Maebashi, Gunma, Japan
Kobe University Hospital ( Site 0015)
Kobe, Hyōgo, Japan
Shikoku Medical Center for Children and Adults ( Site 0027)
Zentsujichó, Kagawa-ken, Japan
Showa University Fujigaoka Hospital ( Site 0023)
Yokohama, Kanagawa, Japan
Kanagawa Children's Medical Center ( Site 0025)
Yokohama, Kanagawa, Japan
National Hospital Organization National Mie Hospital ( Site 0002)
Tsu, Mie-ken, Japan
National Hospital Organization Beppu Medical Center ( Site 0003)
Beppu, Oita Prefecture, Japan
Tokyo Metropolitan Children's Medical Center ( Site 0004)
Fuchū, Tokyo, Japan
...and 6 more locations
Percentage of Participants With an Adverse Event
An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Time frame: Up to 56 days
Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE)
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event.
Time frame: Up to 42 days
Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success
Clinical success in participants with MRSA infections was defined as either "Cure" - Resolution of clinically significant signs and symptoms associated with admission infection and no further antibiotic therapy required, OR "Improved"- partial resolution of clinical signs or symptoms of infection with no further antibiotic therapy required.
Time frame: Up to 7 days following end of treatment (up to 49 days)
Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response
Participant-level microbiological response in participants with MRSA infections at baseline is defined as absence or presumed absence of all baseline infecting pathogens AND no gram-positive superinfection or gram-positive new infection, as assessed by infection site specimen culture or blood culture.
Time frame: Up to 7 days following end of treatment (up to 49 days)
Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin
Blood samples were collected at pre-specified time points to determine the AUC0-24 of daptomycin.
Time frame: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment
Maximum Plasma Concentration (Cmax) of Daptomycin
Blood samples were collected at pre-specified timepoints to determine Cmax of daptomycin.
Time frame: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment
Time to Maximum Plasma Concentration (Tmax) of Daptomycin
Blood samples were collected at pre-specified time points to determine Tmax of daptomycin
Time frame: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment
Body Weight Adjusted Clearance (CLss/wt) of Daptomycin
Blood samples were collected at pre-specified time points to determine CLss/wt of daptomycin at steady state.
Time frame: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment
Volume of Distribution at Steady State (Vss) of Daptomycin
Blood samples were collected at pre-specified time points to determine Vss (mL) of daptomycin.
Time frame: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment
Apparent Terminal Half-Life (t½) of Daptomycin
Blood samples were collected at pre-specified time points to determine the t½ of daptomycin.
Time frame: Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment
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