Adults 1 to 17, any sex, with Bacteremia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With One or More Adverse Events (AEs)Primary· Administration of first dose through the last follow-up visit (up to 77 days)
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.
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
15
Comparator- 1 to 6 Year Olds
6
Daptomycin - 7 to 11 Year Olds
12
Comparator - 7 to 11 Year Olds
9
Daptomycin - 12 to 17 Year Olds
9
Comparator - 12 to 17 Year Olds
5
Number of Participants With One or More Serious Adverse Events (SAEs)Primary· Administration of first dose through the last follow-up visit (up to 77 days)
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.
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
6
Comparator- 1 to 6 Year Olds
2
Daptomycin - 7 to 11 Year Olds
4
Comparator - 7 to 11 Year Olds
3
Daptomycin - 12 to 17 Year Olds
3
Comparator - 12 to 17 Year Olds
2
Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of NormalPrimary· Baseline up to end of therapy visit (up to 49 days)
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) .
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
40.9
Comparator- 1 to 6 Year Olds
40.0
Daptomycin - 7 to 11 Year Olds
10.5
Comparator - 7 to 11 Year Olds
0.0
Daptomycin - 12 to 17 Year Olds
28.6
Comparator - 12 to 17 Year Olds
14.3
Percentage of Participants With Sustained CPK ElevationsPrimary· Baseline up to end of therapy visit (up to 44 days)
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)
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
18.2
Comparator- 1 to 6 Year Olds
20.0
Daptomycin - 7 to 11 Year Olds
0.0
Comparator - 7 to 11 Year Olds
0.0
Daptomycin - 12 to 17 Year Olds
28.6
Comparator - 12 to 17 Year Olds
14.3
Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC)Primary· TOC Safety Visit (up to 56 days)
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.
Alertness
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
0
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
0
Comparator - 12 to 17 Year Olds
0
Pupillary Reflex and Tracking
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
1
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
0
Comparator - 12 to 17 Year Olds
0
Peripheral Reflex - Biceps
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
0
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
0
Comparator - 12 to 17 Year Olds
0
Peripheral Reflex - Patellar Tendon
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
1
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
0
Comparator - 12 to 17 Year Olds
0
Peripheral Reflex - Ankle Jerk
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
1
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
0
Comparator - 12 to 17 Year Olds
0
Peripheral Reflex - Plantar Response
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
0
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
0
Comparator - 12 to 17 Year Olds
0
Muscle Tone - Lower/Upper Limbs
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
0
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
2
Comparator - 12 to 17 Year Olds
0
Muscle Strength - Lower/Upper Limbs
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
0
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
2
Comparator - 12 to 17 Year Olds
0
Percentage of Participants With Clinical Success at TOC/Safety VisitSecondary· 7-14 days after the last dose of study medication (up to 56 days)
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.
Cured
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
80.0
Comparator- 1 to 6 Year Olds
87.5
Daptomycin - 7 to 11 Year Olds
94.1
Comparator - 7 to 11 Year Olds
77.8
Daptomycin - 12 to 17 Year Olds
78.6
Comparator - 12 to 17 Year Olds
60.0
Improved
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
5.0
Comparator- 1 to 6 Year Olds
0
Daptomycin - 7 to 11 Year Olds
0
Comparator - 7 to 11 Year Olds
0
Daptomycin - 12 to 17 Year Olds
7.1
Comparator - 12 to 17 Year Olds
0
Percentage of Participants With Overall Success at TOC VisitSecondary· 7-14 days after the last dose of study medication (up to 56 days)
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.
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
80.0
Comparator- 1 to 6 Year Olds
75.0
Daptomycin - 7 to 11 Year Olds
82.4
Comparator - 7 to 11 Year Olds
44.4
Daptomycin - 12 to 17 Year Olds
50.0
Comparator - 12 to 17 Year Olds
60.0
Trough Plasma Concentration of DaptomycinSecondary· Days 3, 4, 5 or 6 of treatment at pre-dose
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.
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
4.72
± 1.643
Daptomycin - 7 to 11 Year Olds
6.39
± 3.035
Daptomycin - 12 to 17 Year Olds
14.69
± 19.109
Maximum Plasma Concentration (Cmax) of DaptomycinSecondary· Days 3, 4, 5 or 6 of treatment at end of infusion
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.
Group
Value
95% CI
Daptomycin - 1 to 6 Year Olds
96.69
± 32.946
Daptomycin - 7 to 11 Year Olds
87.66
± 34.992
Daptomycin - 12 to 17 Year Olds
74.70
± 34.909
Adverse events — posted to ClinicalTrials.gov
Time frame: Administration of first dose through the last follow-up visit (up to 77 days)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03138733 — Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 28 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01728376.