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| ID | Type | Description | Link |
|---|---|---|---|
| DAP-PEDBAC-11-02 | Other Identifier | Cubist Pharmaceuticals LLC Protocol Number |
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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).
S. 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 S. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin - 12 to 17 year olds | Experimental | Participants 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 olds | Active Comparator | Participants 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 olds | Experimental | Participants 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 olds | Experimental | Participants 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug | Intravenous 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Administration of first dose through the last follow-up visit (up to 77 days) |
| Number of Participants With One or More Serious Adverse Events (SAEs) | An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event. | Administration of first dose through the last follow-up visit (up to 77 days) |
| Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal | Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) . | Baseline up to end of therapy visit (up to 49 days) |
| Percentage of Participants With Sustained CPK Elevations | Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN) | Baseline up to end of therapy visit (up to 44 days) |
| Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Success at TOC/Safety Visit | Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study. |
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Inclusion Criteria:
To be included in this study, participants must:
Exclusion Criteria:
Participants will not be allowed into the study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29406465 | Derived | Arrieta AC, Bradley JS, Popejoy MW, Bensaci M, Grandhi A, Bokesch P, Glasser C, Du L, Patino H, Kartsonis NA. Randomized Multicenter Study Comparing Safety and Efficacy of Daptomycin Versus Standard-of-care in Pediatric Patients With Staphylococcal Bacteremia. Pediatr Infect Dis J. 2018 Sep;37(9):893-900. doi: 10.1097/INF.0000000000001926. |
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Participants aged 1-17 with bacteremia caused by Staphylococcus aureus (S. aureus) were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daptomycin - 1 to 6 Year Olds | Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator - 7 to 11 year olds | Active Comparator | Participants 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 olds | Active Comparator | Participants 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. |
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|
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| Comparator | Drug | Vancomycin, 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. |
|
Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers. |
| TOC Safety Visit (up to 56 days) |
| 7-14 days after the last dose of study medication (up to 56 days) |
| Percentage of Participants With Overall Success at TOC Visit | Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed. | 7-14 days after the last dose of study medication (up to 56 days) |
| Trough Plasma Concentration of Daptomycin | Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded. | Days 3, 4, 5 or 6 of treatment at pre-dose |
| Maximum Plasma Concentration (Cmax) of Daptomycin | Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded. | Days 3, 4, 5 or 6 of treatment at end of infusion |
| FG001 | Comparator- 1 to 6 Year Olds | Participants 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. |
| FG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| FG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| FG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| FG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Participants who received any dose of IV study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Daptomycin - 1 to 6 Year Olds | Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (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). |
| BG001 | Comparator- 1 to 6 Year Olds | Participants 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. |
| BG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| BG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| BG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| BG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. | Participants who received any dose of IV study medication | Posted | Number | Participants | Administration of first dose through the last follow-up visit (up to 77 days) |
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| Primary | Number of Participants With One or More Serious Adverse Events (SAEs) | An SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death, life threatening experience, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is considered to be an important medical event. | Participants who received any dose of IV study medication | Posted | Number | Participants | Administration of first dose through the last follow-up visit (up to 77 days) |
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| Primary | Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal | Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with maximum post-baseline CPK elevations above the upper limit of 500 Units Per Liter (U/L) . | Participants who received any dose of IV study medication | Posted | Number | Percentage of Participants | Baseline up to end of therapy visit (up to 49 days) |
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| Primary | Percentage of Participants With Sustained CPK Elevations | Blood was drawn from baseline up to the end of therapy visit to determine the percentage of participants with sustained CPK elevations, defined as two consecutive post-baseline values above the upper limit of normal (ULN) | Participants who received any dose of IV study medication | Posted | Number | Percentage of Participants | Baseline up to end of therapy visit (up to 44 days) |
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| Primary | Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) | Focused neurological examinations were done at the TOC/Safety Visit. These examinations include assessments of sensation, pupillary reflex and tracking, peripheral reflexes (biceps, patellar tendon, ankle jerk and plantar response), muscle tone and strength (upper and lower limbs), coordination (finger to nose) and tremor of the hands/fingers. | Participants who received any dose of IV study medication. | Posted | Number | Participants | TOC Safety Visit (up to 56 days) |
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| Secondary | Percentage of Participants With Clinical Success at TOC/Safety Visit | Clinical success was determined by assessing resolution/improvement of signs and symptoms. An assessment of cure or improved is considered clinical success. Cure: resolution of clinically significant signs and symptoms associated with admission infection; no further antibiotic therapy is required for the primary infection under study. Improvement: partial resolution of clinical signs/symptoms of infection such that no further antibiotic therapy is required for the primary infection under study. | All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline. | Posted | Number | Percentage of participants | 7-14 days after the last dose of study medication (up to 56 days) |
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| Secondary | Percentage of Participants With Overall Success at TOC Visit | Overall success is based on microbiologic responses after initiating study drug and clinical response at TOC/Safety Visit. Overall outcome is a success if both clinical and microbiologic outcomes are successes. An assessment of cure or improved is considered clinical success. Microbiological Success: a participant for whom all baseline infecting pathogens were eradicated (presumed or documented) within 7 days from the start of study drug for uncomplicated bacteremia with no source of infection present, and 10 days for complicated bacteremia or when the source of infection has not been removed. | All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline. | Posted | Number | Percentage of participants | 7-14 days after the last dose of study medication (up to 56 days) |
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| Secondary | Trough Plasma Concentration of Daptomycin | Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Trough concentrations were collected 22 to 26 hours following the end of the previous day's end of infusion and before the next infusion. Concentrations below the limit of quantification were excluded. | Participants treated with daptomycin with at least one trough sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin. | Posted | Mean | Standard Deviation | µg/mL | Days 3, 4, 5 or 6 of treatment at pre-dose |
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| Secondary | Maximum Plasma Concentration (Cmax) of Daptomycin | Plasma concentrations of daptomycin were measured on Days 3 through 6 of IV dosing. Peak concentrations were collected up to 15 minutes following the end of infusion. Concentrations below the limit of quantification were excluded. | Participants treated with daptomycin with at least one peak sample. Participants in the comparator treatment groups were not analyzed as they were not treated with daptomycin. | Posted | Mean | Standard Deviation | µg/mL | Days 3, 4, 5 or 6 of treatment at end of infusion |
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Administration of first dose through the last follow-up visit (up to 77 days).
Participants who received any dose of IV study medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daptomycin - 1 to 6 Year Olds | Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (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). | 6 | 22 | 9 | 22 | ||
| EG001 | Comparator - 1 to 6 Year Olds | Participants 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. | 2 | 10 | 6 | 10 | ||
| EG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). | 4 | 19 | 11 | 19 | ||
| EG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. | 3 | 9 | 9 | 9 | ||
| EG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). | 3 | 14 | 8 | 14 | ||
| EG005 | Comparator - 12 to 17 Year Olds | Participants 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. | 2 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Device breakage | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Intestine transplant rejection | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Bone abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bone fistula | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Catheter site discharge | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Catheter site oedema | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Device breakage | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Infusion site pain | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Systemic candida | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Varicella | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 17.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Renal necrosis | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Epididymal cyst | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pharyngeal ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 17.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA Version 17.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| OG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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 Olds |
Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
|
|
Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
|
|
| OG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
|
|
| OG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
|
|
|
| OG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
|
|
|
| OG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
|
|
| OG002 | Daptomycin - 7 to 11 Year Olds | Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, 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). |
| OG003 | Comparator - 7 to 11 Year Olds | Participants ages 7-11 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) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator. |
| OG004 | Daptomycin - 12 to 17 Year Olds | Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, 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). |
| OG005 | Comparator - 12 to 17 Year Olds | Participants 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. |
|
|