Trial · NCT03643952
Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
NCT03643952, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2021-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029). Trials, record NCT03643952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03643952
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)
- NCT number
- NCT03643952
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Bacteremia, Soft Tissue Infections, Skin Diseases, Infectious
- Interventions
- Daptomycin for Injection
- First posted
- 2018-08-23
- Last updated
- 2022-05-13
- Other registries' IDs
- eudract:2020-001576-15
- Results first posted
- 2021-03-30
- Limitations and caveats
The study was concluded due to the difficulty of enrolling pediatric patients into the study during the COVID-19 pandemic. This study concluded enrollment with 18 participants, versus the 20 that were originally planned.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Adverse Event | Up to 56 days | An adverse event (AE) is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. |
| Primary | Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE) | Up to 42 days | An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. |
| Secondary | Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success | Up to 7 days following end of treatment (up to 49 days) | Clinical success in participants with MRSA infections was defined as either "Cure" - Resolution of clinically significant signs and symptoms associated with admission infection and no further antibiotic therapy required, OR "Improved"- partial resolution of clinical signs or symptoms of infection with no further antibiotic therapy required. |
| Secondary | Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response | Up to 7 days following end of treatment (up to 49 days) | Participant-level microbiological response in participants with MRSA infections at baseline is defined as absence or presumed absence of all baseline infecting pathogens AND no gram-positive superinfection or gram-positive new infection, as assessed by infection site specimen culture or blood culture. |
| Secondary | Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | Blood samples were collected at pre-specified time points to determine the AUC0-24 of daptomycin. |
| Secondary | Maximum Plasma Concentration (Cmax) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | Blood samples were collected at pre-specified timepoints to determine Cmax of daptomycin. |
| Secondary | Time to Maximum Plasma Concentration (Tmax) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | Blood samples were collected at pre-specified time points to determine Tmax of daptomycin |
| Secondary | Body Weight Adjusted Clearance (CLss/wt) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | Blood samples were collected at pre-specified time points to determine CLss/wt of daptomycin at steady state. |
| Secondary | Volume of Distribution at Steady State (Vss) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | Blood samples were collected at pre-specified time points to determine Vss (mL) of daptomycin. |
| Secondary | Apparent Terminal Half-Life (t½) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | Blood samples were collected at pre-specified time points to determine the t½ of daptomycin. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Adverse Event | Up to 56 days | All enrolled participants who received at least one dose of daptomycin | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE) | Up to 42 days | All enrolled participants who received at least one dose of daptomycin | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success | Up to 7 days following end of treatment (up to 49 days) | All enrolled participants with cSSTI or bacteremia who had a positive culture of MRSA at baseline and received at least one dose of study treatment | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response | Up to 7 days following end of treatment (up to 49 days) | All enrolled participants with cSSTI or bacteremia who had a positive culture of MRSA at baseline and received at least one dose of study treatment | Percentage of Participants | NUMBER |
| SECONDARY | Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | All enrolled participants who received at least 3 consecutive intravenous (IV) infusions of study treatment, had at least 1 pharmacokinetic (PK) sample following study drug administration, and did not have any protocol violations affecting the PK profile | µg·hr/mL | MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile | μg/mL | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile | Hours | MEDIAN |
| SECONDARY | Body Weight Adjusted Clearance (CLss/wt) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile | mL/hr/kg | MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vss) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile | mL | MEAN |
| SECONDARY | Apparent Terminal Half-Life (t½) of Daptomycin | Pre-dose and at 15 minutes, 1 hour, 4 hours, and 12 hours post-dose on Day 3 of daptomycin treatment | All enrolled participants who received at least 3 consecutive IV infusions of study treatment, had at least 1 PK sample following study drug administration, and did not have any protocol violations affecting the PK profile | Hours | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Adverse Event | Daptomycin | 55.6 | Percentage of Participants | ||
| Percentage of Participants That Discontinued Study Treatment Due to an Adverse Event (AE) | Daptomycin | 0 | Percentage of Participants | ||
| Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success | Daptomycin (MRSA With cSSTI) | 85.7 | 95% Confidence Interval 42.1 to 99.6 | Percentage of Participants | |
| Percentage of Participants With Methicillin-Resistant Staphylococcus Aureus (MRSA) Infections Who Experienced Clinical Success | Daptomycin (MRSA With Bacteremia) | 100 | 95% Confidence Interval 2.5 to 100 | Percentage of Participants | |
| Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response | Daptomycin (MRSA With cSSTI) | 71.4 | 95% Confidence Interval 29.0 to 96.3 | Percentage of Participants | |
| Percentage of Participants With MRSA Infections Who Experienced a Microbiological Response | Daptomycin (MRSA With Bacteremia) | 100 | 95% Confidence Interval 2.5 to 100 | Percentage of Participants | |
| Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin | Daptomycin (cSSTI) | Age Category 1-<2 years | 574 | Standard Deviation 99.1 | µg·hr/mL |
| Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin | Daptomycin (Bacteremia) | Age Category 1-<2 years | 502 | Standard Deviation 0 | µg·hr/mL |
| Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin | Daptomycin (cSSTI) | Age Category 2-6 years | 431 | Standard Deviation 53.6 | µg·hr/mL |
| Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24hr) of Daptomycin | Daptomycin (cSSTI) | Age Category 7-11 years | 409 | Standard Deviation 143 | µg·hr/mL |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Daptomycin | 18 | |
| Overall Study | COMPLETED | Daptomycin | 17 | |
| Overall Study | NOT COMPLETED | Daptomycin | 1 |
Source ClinicalTrials.gov
Adverse events19
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 | Constipation | Gastrointestinal disorders | Daptomycin | 1 | 18 | 1 |
| other | Enterocolitis | Gastrointestinal disorders | Daptomycin | 1 | 18 | 1 |
| other | Gastrointestinal mucosal disorder | Gastrointestinal disorders | Daptomycin | 1 | 18 | 1 |
| other | Catheter site related reaction | General disorders | Daptomycin | 1 | 18 | 1 |
| other | Chills | General disorders | Daptomycin | 1 | 18 | 1 |
| other | Infusion site swelling | General disorders | Daptomycin | 1 | 18 | 1 |
| other | Injection site pain | General disorders | Daptomycin | 1 | 18 | 1 |
| other | Pyrexia | General disorders | Daptomycin | 2 | 18 | 2 |
| other | Gastroenteritis viral | Infections and infestations | Daptomycin | 1 | 18 | 1 |
| other | Genital candidiasis | Infections and infestations | Daptomycin | 1 | 18 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daptomycin | 0 | 18 |
| Total, other adverse events | Daptomycin | 10 | 18 |
| Total, serious adverse events | Daptomycin | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34920946 | RESULT |
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.
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