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| ID | Type | Description | Link |
|---|---|---|---|
| DAP-PEDS-07-03 | Other Identifier | Cubist Study Number |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin | Experimental | Administered intravenously (IV) every 24 hours for up to 14 days at the following age-dependent dosages. Participants ages 7 to 17 years: daptomycin was dissolved in a volume of 50 milliliters (mL) 0.9% sodium chloride for injection over 30 minutes (min) with an infusion rate of 1.67 mL/min. Participants 1 to 6 years-old: daptomycin was dissolved in a volume of 25 mL 0.9% sodium chloride for injection over 60 min with an infusion rate was 0.42 mL/min. Age Group 1 (for ages 12 to 17 years): 5 milligrams/kilogram (mg/kg) Age Group 2 (for ages 7 to 11 years): 7 mg/kg Age Group 3 (for ages 2 to 6 years): 9 mg/kg Age Group 4 (for ages 1 to <2 years): 10 mg/kg |
|
| Standard of Care (SOC) | Active Comparator | The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug |
|
| |
| Standard of Care (SOC) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Baseline through 14 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit | The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as "Success" or "Failure" by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered "Success" by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of "Failure" was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was "Failure." If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was "Unable to evaluate." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellie Hershberger | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Children's Hospital Research Center Oakland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28202770 | Result | Bradley J, Glasser C, Patino H, Arnold SR, Arrieta A, Congeni B, Daum RS, Kojaoghlanian T, Yoon M, Anastasiou D, Wolf DJ, Bokesch P. Daptomycin for Complicated Skin Infections: A Randomized Trial. Pediatrics. 2017 Mar;139(3):e20162477. doi: 10.1542/peds.2016-2477. Epub 2017 Feb 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Age Group 1: Daptomycin | Daptomycin: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years |
| FG001 | Age Group 1: Standard of Care (SOC) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Baseline through 14 days after last dose of study drug |
| Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t]) | Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points: Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion. | Predose and 5 timepoints according to age group (up to 12 hours postdose) |
| 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 |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Montifiore Medical Center | The Bronx | New York | 10467 | 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 |
| 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 City | Panama |
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
| FG002 | Age Group 2: Daptomycin | Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years |
| FG003 | Age Group 2: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years |
| FG004 | Age Group 3: Daptomycin | Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years |
| FG005 | Age Group 3: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years |
| FG006 | Age Group 4: Daptomycin | Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years |
| FG007 | Age Group 4: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Age Group 1: Daptomycin | Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years |
| BG001 | Age Group 1: Standard of Care (SOC) | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years |
| BG002 | Age Group 2: Daptomycin | Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years |
| BG003 | Age Group 2: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years |
| BG004 | Age Group 3: Daptomycin | Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years |
| BG005 | Age Group 3: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years |
| BG006 | Age Group 4: Daptomycin | Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years |
| BG007 | Age Group 4: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as any treatment-emergent adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing adverse AEs that were aggravated in severity or frequency during the dosing period. The percentage of participants with at least 1 TEAE, with at least one drug-related AE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data. | Posted | Number | percentage of participants | Baseline through 14 days after last dose of study drug |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit | The assessment of therapeutic response was determined by comparing a participant's signs and symptoms at the test of cure visit (up to 14 days after last dose) to those recorded at baseline. Participants were classified as "Success" or "Failure" by combining their clinical and microbiological efficacy responses. Resolution of clinically significant signs and symptoms associated with the skin infection present at study baseline was considered "Success" by the Investigator. These participants were deemed both clinically cured and microbiologically eradicated. For participants whose clinical course could not be clearly defined as improved, a clinical outcome of "Failure" was rendered. In addition, if it was determined that the primary site of infection required additional antibiotic treatment, the assessment of clinical response was "Failure." If the Investigator was unable to determine a response because the participant was lost to follow-up, the assessment was "Unable to evaluate." | Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data. | Posted | Number | percentage of participants | Baseline through 14 days after last dose of study drug |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t]) | Participants who volunteered for PK sampling had a blood sample collected for analysis at the following time points: Age Group 1; Day 3: Predose, 0.25 hour (hr), 1 hr, 4 hr, and12 hr postdose. Age Group 2; Day 3: Predose, 0.25 hr, 1 hr, 6 hr, and 10 hr postdose. Age Group 3; Day 1, 2, or 3: Predose, 0.25 hr, 1 hr, 6 hr, and 8 hr postdose. Age Group 4; Day 1, 2, or 3: 0, 1, 2, 4, and 6 hr relative to end of infusion. | Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data. | Posted | Mean | Standard Deviation | microgram*hour per milliliter (μg*hr/mL) | Predose and 5 timepoints according to age group (up to 12 hours postdose) |
|
Baseline through 14 days after last dose of study drug
Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data are included. Participants who experience more than one event are counted only once per System Organ Class and Preferred Term.
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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 | Age Group 1: Daptomycin | Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years | 3 | 72 | 15 | 72 | ||
| EG001 | Age Group 1: Standard of Care (SOC) | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 1: Participants ages 12 to 17 years | 1 | 38 | 9 | 38 | ||
| EG002 | Age Group 2: Daptomycin | Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years | 1 | 73 | 7 | 73 | ||
| EG003 | Age Group 2: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years | 1 | 38 | 2 | 38 | ||
| EG004 | Age Group 3: Daptomycin | Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years | 2 | 81 | 27 | 81 | ||
| EG005 | Age Group 3: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years | 1 | 42 | 10 | 42 | ||
| EG006 | Age Group 4: Daptomycin | Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years | 0 | 30 | 11 | 30 | ||
| EG007 | Age Group 4: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years | 0 | 15 | 11 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (11.0) |
| ||
| Pyrexia | General disorders | MedDRA (11.0) |
| ||
| Abscess | Infections and infestations | MedDRA (11.0) |
| ||
| Bacteraemia | Infections and infestations | MedDRA (11.0) |
| ||
| Osteomyelitis | Infections and infestations | MedDRA (11.0) |
| ||
| Subcutaneous abscess | Infections and infestations | MedDRA (11.0) |
| ||
| Blood creatine phosphokinase increased | Investigations | MedDRA (11.0) |
| ||
| Myopathy | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
| ||
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
| ||
| Wound drainage | Surgical and medical procedures | MedDRA (11.0) |
| ||
| Toxic shock syndrome | Infections and infestations | MedDRA (11.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cheilitis | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) |
| ||
| Infusion site extravasation | General disorders | MedDRA (11.0) |
| ||
| Infusion site pain | General disorders | MedDRA (11.0) |
| ||
| Pyrexia | General disorders | MedDRA (11.0) |
| ||
| Abscess neck | Infections and infestations | MedDRA (11.0) |
| ||
| Candida nappy rash | Infections and infestations | MedDRA (11.0) |
| ||
| Cellulitis | Infections and infestations | MedDRA (11.0) |
| ||
| Fungal infection | Infections and infestations | MedDRA (11.0) |
| ||
| Genital candidiasis | Infections and infestations | MedDRA (11.0) |
| ||
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA (11.0) |
| ||
| Rhinitis | Infections and infestations | MedDRA (11.0) |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) |
| ||
| Blood creatine phosphokinase increased | Investigations | MedDRA (11.0) |
| ||
| Blood phosphorus increased | Investigations | MedDRA (11.0) |
| ||
| Lymphocyte percentage increase | Investigations | MedDRA (11.0) |
| ||
| Neutrophil count decreased | Investigations | MedDRA (11.0) |
| ||
| Platelet count increased | Investigations | MedDRA (11.0) |
| ||
| Red blood cells urine | Investigations | MedDRA (11.0) |
| ||
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (11.0) |
| ||
| Headache | Nervous system disorders | MedDRA (11.0) |
| ||
| Pharyngeal lesion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) |
| ||
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | Cubist Pharmaceuticals | (781) 860-8660 |
| ID | Term |
|---|---|
| D012874 | Skin Diseases, Infectious |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| D059039 | Standard of Care |
| D009254 | Nafcillin |
| D010068 | Oxacillin |
| D003023 | Cloxacillin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| At least 1 drug-related TEAE |
|
| Discontinued treatment due to a TEAE |
|
SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days.
Age Group 1: Participants ages 12 to 17 years
| OG002 | Age Group 2: Daptomycin | Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years |
| OG003 | Age Group 2: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 2: Participants ages 7 to 11 years |
| OG004 | Age Group 3: Daptomycin | Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years |
| OG005 | Age Group 3: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 3: Participants ages 2 to 6 years |
| OG006 | Age Group 4: Daptomycin | Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years |
| OG007 | Age Group 4: SOC | SOC: The comparator agent for this study was the SOC treatment and dosage deemed appropriate by the Investigator. The recommended SOC agents were IV vancomycin, IV clindamycin, and IV semisynthetic penicillins every 24 hours for up to 14 days. Age Group 4: Participants ages 1 to <2 years |
|
|
| OG003 | Age Group 4: Daptomycin | Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years |
|
|