Trial · NCT01728376
Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
NCT01728376, Phase 4, Completed, Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2016-12-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005). Trials, record NCT01728376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01728376
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
- NCT number
- NCT01728376
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 82 participants, actual
- Lead sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Bacteremia
- Interventions
- Daptomycin, Comparator
- First posted
- 2012-11-19
- Last updated
- 2018-08-28
- Results first posted
- 2016-12-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With One or More Adverse Events (AEs) | 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. |
| Primary | Number of Participants With One or More Serious Adverse Events (SAEs) | 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. |
| Primary | Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal | 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) . |
| Primary | Percentage of Participants With Sustained CPK Elevations | 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) |
| Primary | Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) | 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. |
| Secondary | Percentage of Participants With Clinical Success at TOC/Safety Visit | 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. |
| Secondary | Percentage of Participants With Overall Success at TOC Visit | 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. |
| Secondary | Trough Plasma Concentration of Daptomycin | 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. |
| Secondary | Maximum Plasma Concentration (Cmax) of Daptomycin | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With One or More Adverse Events (AEs) | Administration of first dose through the last follow-up visit (up to 77 days) | Participants who received any dose of IV study medication | Participants | NUMBER |
| PRIMARY | Number of Participants With One or More Serious Adverse Events (SAEs) | Administration of first dose through the last follow-up visit (up to 77 days) | Participants who received any dose of IV study medication | Participants | NUMBER |
| PRIMARY | Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal | Baseline up to end of therapy visit (up to 49 days) | Participants who received any dose of IV study medication | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Sustained CPK Elevations | Baseline up to end of therapy visit (up to 44 days) | Participants who received any dose of IV study medication | Percentage of Participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) | TOC Safety Visit (up to 56 days) | Participants who received any dose of IV study medication. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Success at TOC/Safety Visit | 7-14 days after the last dose of study medication (up to 56 days) | All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall Success at TOC Visit | 7-14 days after the last dose of study medication (up to 56 days) | All randomized and treated participants who received ≥1 dose of study drug and who had proven S. aureus bacteremia at baseline. | Percentage of participants | NUMBER |
| SECONDARY | Trough Plasma Concentration of Daptomycin | Days 3, 4, 5 or 6 of treatment at pre-dose | 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. | µg/mL | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Daptomycin | Days 3, 4, 5 or 6 of treatment at end of infusion | 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. | µg/mL | MEAN |
Source ClinicalTrials.gov
Results by group114
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With One or More Adverse Events (AEs) | Daptomycin - 1 to 6 Year Olds | 15 | Participants | ||
| Number of Participants With One or More Adverse Events (AEs) | Comparator- 1 to 6 Year Olds | 6 | Participants | ||
| Number of Participants With One or More Adverse Events (AEs) | Daptomycin - 7 to 11 Year Olds | 12 | Participants | ||
| Number of Participants With One or More Adverse Events (AEs) | Comparator - 7 to 11 Year Olds | 9 | Participants | ||
| Number of Participants With One or More Adverse Events (AEs) | Daptomycin - 12 to 17 Year Olds | 9 | Participants | ||
| Number of Participants With One or More Adverse Events (AEs) | Comparator - 12 to 17 Year Olds | 5 | Participants | ||
| Number of Participants With One or More Serious Adverse Events (SAEs) | Daptomycin - 1 to 6 Year Olds | 6 | Participants | ||
| Number of Participants With One or More Serious Adverse Events (SAEs) | Comparator- 1 to 6 Year Olds | 2 | Participants | ||
| Number of Participants With One or More Serious Adverse Events (SAEs) | Daptomycin - 7 to 11 Year Olds | 4 | Participants | ||
| Number of Participants With One or More Serious Adverse Events (SAEs) | Comparator - 7 to 11 Year Olds | 3 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daptomycin - 1 to 6 Year Olds | 22 | |
| Overall Study | STARTED | Comparator- 1 to 6 Year Olds | 11 | |
| Overall Study | STARTED | Daptomycin - 7 to 11 Year Olds | 19 | |
| Overall Study | STARTED | Comparator - 7 to 11 Year Olds | 9 | |
| Overall Study | STARTED | Daptomycin - 12 to 17 Year Olds | 14 | |
| Overall Study | STARTED | Comparator - 12 to 17 Year Olds | 7 | |
| Overall Study | Treated | Daptomycin - 1 to 6 Year Olds | 22 | |
| Overall Study | Treated | Comparator- 1 to 6 Year Olds | 10 | |
| Overall Study | Treated | Daptomycin - 7 to 11 Year Olds | 19 | |
| Overall Study | Treated | Comparator - 7 to 11 Year Olds | 9 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events606
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal lymphadenopathy | Blood and lymphatic system disorders | Daptomycin - 1 to 6 Year Olds | 0 | 22 | 0 |
| other | Abdominal lymphadenopathy | Blood and lymphatic system disorders | Comparator - 1 to 6 Year Olds | 0 | 10 | 0 |
| other | Abdominal lymphadenopathy | Blood and lymphatic system disorders | Daptomycin - 7 to 11 Year Olds | 0 | 19 | 0 |
| other | Abdominal lymphadenopathy | Blood and lymphatic system disorders | Comparator - 7 to 11 Year Olds | 1 | 9 | 1 |
| other | Abdominal lymphadenopathy | Blood and lymphatic system disorders | Daptomycin - 12 to 17 Year Olds | 0 | 14 | 0 |
| other | Abdominal lymphadenopathy | Blood and lymphatic system disorders | Comparator - 12 to 17 Year Olds | 0 | 7 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Daptomycin - 1 to 6 Year Olds | 0 | 22 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Comparator - 1 to 6 Year Olds | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Daptomycin - 7 to 11 Year Olds | 1 | 19 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Comparator - 7 to 11 Year Olds | 1 | 9 | 1 |
1 to 10 of 606Source ClinicalTrials.gov
See all 606 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daptomycin - 1 to 6 Year Olds | ||
| Total, all-cause mortality | Comparator - 1 to 6 Year Olds | ||
| Total, all-cause mortality | Daptomycin - 7 to 11 Year Olds | ||
| Total, all-cause mortality | Comparator - 7 to 11 Year Olds | ||
| Total, all-cause mortality | Daptomycin - 12 to 17 Year Olds | ||
| Total, all-cause mortality | Comparator - 12 to 17 Year Olds | ||
| Total, other adverse events | Daptomycin - 1 to 6 Year Olds | 9 | 22 |
| Total, other adverse events | Comparator - 1 to 6 Year Olds | 6 | 10 |
| Total, other adverse events | Daptomycin - 7 to 11 Year Olds | 11 | 19 |
| Total, other adverse events | Comparator - 7 to 11 Year Olds | 9 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29406465 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01728376
GET https://conductscience.org/api/trials/v1/NCT01728376/results?page=2