Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections

• ClinicalTrials.gov Identifier: NCT00711802
• Recruitment Status: Completed
• First Posted: July 9, 2008
• Results First Posted: June 10, 2015
• Last Update Posted: September 5, 2018
• Sponsor: Cubist Pharmaceuticals LLC
• Information provided by (Responsible Party): Cubist Pharmaceuticals LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Skin Diseases, Infectious
• Interventions: Drug: Daptomycin; Drug: Standard of Care (SOC)
• Enrollment: 396

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
Arm/Group Description	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	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	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years	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	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years	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	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years	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
Period Title: Overall Study
Started	75	38	75	38	83	42	30	15
Received at Least 1 Dose of Study Drug	73	37	73	38	81	42	30	15
Completed	73	32	69	35	69	34	25	13
Not Completed	2	6	6	3	14	8	5	2
Reason Not Completed
Not treated (no further detail)	2	1	2	0	2	0	0	0
Adverse Event	0	0	0	0	1	1	0	0
Microbiological failure	0	1	0	0	0	1	0	0
Protocol Violation	0	0	0	1	0	0	0	0
Physician Decision	0	2	0	0	0	0	0	0
Withdrawal by Subject	0	1	0	1	0	0	0	0
Lost to Follow-up	0	0	3	1	10	6	4	2
Reason not reported	0	1	1	0	1	0	1	0

Baseline Characteristics

Arm/Group Title		Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC	Total
Arm/Group Description		Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years	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	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years	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	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years	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	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years	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	Total of all reporting groups
Overall Number of Baseline Participants		73	37	73	38	81	42	30	15	389
Baseline Analysis Population Description		All participants who received at least 1 dose of study drug
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	73 participants	37 participants	73 participants	38 participants	81 participants	42 participants	30 participants	15 participants	389 participants
		15.02 (1.584)	14.84 (1.735)	9.05 (1.443)	8.98 (1.305)	3.92 (1.556)	3.86 (1.555)	1.46 (0.299)	1.43 (0.299)	8.21 (5.134)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	73 participants	37 participants	73 participants	38 participants	81 participants	42 participants	30 participants	15 participants	389 participants
	Female	29 39.7%	15 40.5%	28 38.4%	15 39.5%	48 59.3%	20 47.6%	21 70.0%	12 80.0%	188 48.3%
	Male	44 60.3%	22 59.5%	45 61.6%	23 60.5%	33 40.7%	22 52.4%	9 30.0%	3 20.0%	201 51.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	73 participants	37 participants	73 participants	38 participants	81 participants	42 participants	30 participants	15 participants	389 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	33 45.2%	16 43.2%	49 67.1%	25 65.8%	1 1.2%	0 0.0%	0 0.0%	1 6.7%	125 32.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	12 16.4%	6 16.2%	8 11.0%	5 13.2%	33 40.7%	10 23.8%	12 40.0%	4 26.7%	90 23.1%
	White	28 38.4%	14 37.8%	15 20.5%	7 18.4%	43 53.1%	31 73.8%	18 60.0%	9 60.0%	165 42.4%
	More than one race	0 0.0%	0 0.0%	0 0.0%	1 2.6%	0 0.0%	1 2.4%	0 0.0%	0 0.0%	2 0.5%
	Unknown or Not Reported	0 0.0%	1 2.7%	1 1.4%	0 0.0%	4 4.9%	0 0.0%	0 0.0%	1 6.7%	7 1.8%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	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.
Time Frame	Baseline through 14 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug with evaluable post-baseline TEAE data.

Arm/Group Title	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
Arm/Group Description:	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years	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	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years	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	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years	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	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years	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
Overall Number of Participants Analyzed	72	38	73	38	81	42	30	15
Measure Type: Number; Unit of Measure: percentage of participants
At least 1 TEAE	36.1	36.8	23.3	18.4	50.6	38.1	46.7	73.3
At least 1 drug-related TEAE	13.9	10.5	5.5	10.5	22.2	21.4	10.0	33.3
Discontinued treatment due to a TEAE	2.8	0	1.4	0	3.7	14.3	3.3	6.7

2. Secondary Outcome

Title	Percentage of Participants With an Overall Therapeutic Response at Test of Cure Visit
Description	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."
Time Frame	Baseline through 14 days after last dose of study drug

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug with evaluable test-of-cure visit data.

Arm/Group Title	Age Group 1: Daptomycin	Age Group 1: Standard of Care (SOC)	Age Group 2: Daptomycin	Age Group 2: SOC	Age Group 3: Daptomycin	Age Group 3: SOC	Age Group 4: Daptomycin	Age Group 4: SOC
Arm/Group Description:	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years	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	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years	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	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years	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	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years	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
Overall Number of Participants Analyzed	73	37	73	38	81	42	30	15
Measure Type: Number; Unit of Measure: percentage of participants
Clinical success	95.9	91.9	90.4	92.1	82.7	76.2	80.0	86.7
Clinical failure	0	2.7	2.7	0	1.2	0	0	0
Unable to evaluate	4.1	5.4	6.9	7.9	16.1	23.8	20.0	13.3

3. Secondary Outcome

Title	Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve for Daptomycin From 0 to the Last Sampling Time Point (AUC[0-t])
Description	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.
Time Frame	Predose and 5 timepoints according to age group (up to 12 hours postdose)

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug with evaluable daptomycin AUC(0-t) data.

Arm/Group Title	Age Group 1: Daptomycin	Age Group 2: Daptomycin	Age Group 3: Daptomycin	Age Group 4: Daptomycin
Arm/Group Description:	Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years	Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years	Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years	Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years
Overall Number of Participants Analyzed	6	2	7	30
Mean (Standard Deviation); Unit of Measure: microgram*hour per milliliter (μg*hr/mL)
	318 (62.2)	NA [1] (NA)	318 (68.6)	466 [2] (NA)

[1]

Due to limited pharmacokinetic (PK) samples, these measures could not be calculated.

[2]

Due to limited PK samples, PK parameters were computed using the mean concentration-time profile during a sampling interval. As a result, no variability could be calculated.

Adverse Events

Time Frame

Baseline through 14 days after last dose of study drug

Adverse Event Reporting Description

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.

Arm/Group Title

Age Group 1: Daptomycin

Age Group 1: Standard of Care (SOC)

Age Group 2: Daptomycin

Age Group 2: SOC

Age Group 3: Daptomycin

Age Group 3: SOC

Age Group 4: Daptomycin

Age Group 4: SOC

Arm/Group Description

Daptomycin: 5 mg/kg administered IV every 24 hours for up to 14 days Age Group 1: Participants ages 12 to 17 years

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

Daptomycin: 7 mg/kg administered IV every 24 hours for up to 14 days Age Group 2: Participants ages 7 to 11 years

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

Daptomycin: 9 mg/kg administered IV every 24 hours for up to 14 days Age Group 3: Participants ages 2 to 6 years

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

Daptomycin: 10 mg/kg administered IV every 24 hours for up to 14 days Age Group 4: Participants ages 1 to <2 years

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

All-Cause Mortality

Age Group 1: Daptomycin

Age Group 1: Standard of Care (SOC)

Age Group 2: Daptomycin

Age Group 2: SOC

Age Group 3: Daptomycin

Age Group 3: SOC

Age Group 4: Daptomycin

Age Group 4: SOC

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

--/--

--/--

--/--

--/--

--/--

--/--

Serious Adverse Events

Age Group 1: Daptomycin

Age Group 1: Standard of Care (SOC)

Age Group 2: Daptomycin

Age Group 2: SOC

Age Group 3: Daptomycin

Age Group 3: SOC

Age Group 4: Daptomycin

Age Group 4: SOC

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

3/72 (4.17%)

1/38 (2.63%)

1/73 (1.37%)

1/38 (2.63%)

2/81 (2.47%)

1/42 (2.38%)

0/30 (0.00%)

0/15 (0.00%)

General disorders

Chest pain 1

1/72 (1.39%)

1

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Pyrexia 1

0/72 (0.00%)

0

0/38 (0.00%)

0

1/73 (1.37%)

1

0/38 (0.00%)

0

1/81 (1.23%)

1

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Infections and infestations

Abscess 1

0/72 (0.00%)

0

0/38 (0.00%)

0

1/73 (1.37%)

1

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Bacteraemia 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

1/42 (2.38%)

1

0/30 (0.00%)

0

0/15 (0.00%)

0

Osteomyelitis 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

1/38 (2.63%)

2

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Subcutaneous abscess 1

1/72 (1.39%)

1

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Toxic shock syndrome 1

0/72 (0.00%)

0

1/38 (2.63%)

1

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Investigations

Blood creatine phosphokinase increased 1

1/72 (1.39%)

1

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Musculoskeletal and connective tissue disorders

Myopathy 1

1/72 (1.39%)

1

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Respiratory, thoracic and mediastinal disorders

Status asthmaticus 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

1/81 (1.23%)

1

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Surgical and medical procedures

Wound drainage 1

0/72 (0.00%)

0

0/38 (0.00%)

0

1/73 (1.37%)

1

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

1 Term from vocabulary, MedDRA (11.0)

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

1.0%

Age Group 1: Daptomycin

Age Group 1: Standard of Care (SOC)

Age Group 2: Daptomycin

Age Group 2: SOC

Age Group 3: Daptomycin

Age Group 3: SOC

Age Group 4: Daptomycin

Age Group 4: SOC

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

15/72 (20.83%)

9/38 (23.68%)

7/73 (9.59%)

2/38 (5.26%)

27/81 (33.33%)

10/42 (23.81%)

11/30 (36.67%)

11/15 (73.33%)

Gastrointestinal disorders

Cheilitis 1

0/72 (0.00%)

0

1/38 (2.63%)

1

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Diarrhoea 1

3/72 (4.17%)

3

1/38 (2.63%)

1

3/73 (4.11%)

3

1/38 (2.63%)

1

12/81 (14.81%)

13

4/42 (9.52%)

4

0/30 (0.00%)

0

1/15 (6.67%)

1

Nausea 1

2/72 (2.78%)

3

0/38 (0.00%)

0

1/73 (1.37%)

1

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Vomiting 1

0/72 (0.00%)

0

0/38 (0.00%)

0

1/73 (1.37%)

1

0/38 (0.00%)

0

4/81 (4.94%)

4

1/42 (2.38%)

1

2/30 (6.67%)

3

0/15 (0.00%)

0

General disorders

Infusion site extravasation 1

1/72 (1.39%)

1

1/38 (2.63%)

1

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Infusion site pain 1

1/72 (1.39%)

1

2/38 (5.26%)

2

1/73 (1.37%)

1

0/38 (0.00%)

0

1/81 (1.23%)

1

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Pyrexia 1

2/72 (2.78%)

2

0/38 (0.00%)

0

4/73 (5.48%)

4

0/38 (0.00%)

0

1/81 (1.23%)

1

1/42 (2.38%)

1

2/30 (6.67%)

2

3/15 (20.00%)

3

Infections and infestations

Abscess neck 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Candida nappy rash 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

1/30 (3.33%)

1

1/15 (6.67%)

1

Cellulitis 1

1/72 (1.39%)

1

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

1/81 (1.23%)

1

0/42 (0.00%)

0

2/30 (6.67%)

2

0/15 (0.00%)

0

Fungal infection 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

1/81 (1.23%)

1

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Genital candidiasis 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Hand-foot-and-mouth disease 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Rhinitis 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Upper respiratory tract infection 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

1/38 (2.63%)

1

0/81 (0.00%)

0

1/42 (2.38%)

1

0/30 (0.00%)

0

1/15 (6.67%)

1

Investigations

Blood creatine phosphokinase increased 1

4/72 (5.56%)

4

2/38 (5.26%)

2

0/73 (0.00%)

0

1/38 (2.63%)

1

8/81 (9.88%)

8

2/42 (4.76%)

2

1/30 (3.33%)

1

2/15 (13.33%)

2

Blood phosphorus increased 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

1/81 (1.23%)

1

0/42 (0.00%)

0

1/30 (3.33%)

1

1/15 (6.67%)

1

Lymphocyte percentage increase 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Neutrophil count decreased 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Platelet count increased 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Red blood cells urine 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Metabolism and nutrition disorders

Hyperphosphataemia 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

1/81 (1.23%)

1

0/42 (0.00%)

0

2/30 (6.67%)

2

0/15 (0.00%)

0

Nervous system disorders

Headache 1

5/72 (6.94%)

5

3/38 (7.89%)

4

2/73 (2.74%)

2

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

0/15 (0.00%)

0

Respiratory, thoracic and mediastinal disorders

Pharyngeal lesion 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

0/42 (0.00%)

0

0/30 (0.00%)

0

1/15 (6.67%)

1

Rhinorrhoea 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

1/38 (2.63%)

1

2/81 (2.47%)

2

0/42 (0.00%)

0

2/30 (6.67%)

2

0/15 (0.00%)

0

Skin and subcutaneous tissue disorders

Dermatitis diaper 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

1/42 (2.38%)

1

2/30 (6.67%)

2

2/15 (13.33%)

2

Rash 1

0/72 (0.00%)

0

1/38 (2.63%)

1

0/73 (0.00%)

0

0/38 (0.00%)

0

1/81 (1.23%)

1

2/42 (4.76%)

2

0/30 (0.00%)

0

1/15 (6.67%)

1

Rash papular 1

1/72 (1.39%)

1

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

1/42 (2.38%)

1

2/30 (6.67%)

2

0/15 (0.00%)

0

Urticaria 1

0/72 (0.00%)

0

0/38 (0.00%)

0

0/73 (0.00%)

0

0/38 (0.00%)

0

0/81 (0.00%)

0

1/42 (2.38%)

1

0/30 (0.00%)

0

1/15 (6.67%)

1

1 Term from vocabulary, MedDRA (11.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Vice President, Clinical Research
• Organization: Cubist Pharmaceuticals
• Phone: (781) 860-8660

Publications of Results:

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). pii: e20162477. doi: 10.1542/peds.2016-2477. Epub 2017 Feb 15.

• Responsible Party: Cubist Pharmaceuticals LLC
• ClinicalTrials.gov Identifier: NCT00711802 History of Changes
• Other Study ID Numbers: 3009-017; DAP-PEDS-07-03 ( Other Identifier: Cubist Study Number )
• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Results First Submitted: May 27, 2015
• Results First Posted: June 10, 2015
• Last Update Posted: September 5, 2018