Phase 4
Completed N=82
Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
Source: ClinicalTrials.gov NCT01728376 ↗Enrolled (actual)
82
Serious AEs
24.7%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With One or More Adverse Events (AEs) — 15; 6; 12; 9 Participants
◆ Published Evidence
Established
57citations · ~7 / year
Randomized Multicenter Study Comparing Safety and Efficacy of Daptomycin Versus Standard-of-care in Pediatric Patients With Staphylococcal Bacteremia.
Summary
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).
Linked Publications
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Randomized Multicenter Study Comparing Safety and Efficacy of Daptomycin Versus Standard-of-care in Pediatric Patients With Staphylococcal Bacteremia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Adverse Events (AEs) |
15; 6; 12; 9; 9; 5 | — |
| PRIMARY Number of Participants With One or More Serious Adverse Events (SAEs) |
6; 2; 4; 3; 3; 2 | — |
| PRIMARY Percentage of Participants With Maximum Post-Baseline Creatine Phosphokinase (CPK) Elevations Above Upper Limit of Normal |
40.9; 40.0; 10.5; 0.0; 28.6; 14.3 | — |
| PRIMARY Percentage of Participants With Sustained CPK Elevations |
18.2; 20.0; 0.0; 0.0; 28.6; 14.3 | — |
| PRIMARY Number of Participants With Abnormal Focused (Peripheral) Neurological Assessments at Test of Cure (TOC) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Clinical Success at TOC/Safety Visit |
80.0; 87.5; 94.1; 77.8; 78.6; 60.0 | — |
| SECONDARY Percentage of Participants With Overall Success at TOC Visit |
80.0; 75.0; 82.4; 44.4; 50.0; 60.0 | — |
| SECONDARY Trough Plasma Concentration of Daptomycin |
4.72; 6.39; 14.69 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Daptomycin |
96.69; 87.66; 74.70 | — |
Eligibility Criteria
Inclusion Criteria
To be included in this study, participants must:
- Sign a parental consent form; if appropriate, sign an assent form
- Be between 1 and 17 years of age
- Have proven or probable bacteremia caused by S. aureus based on the traditional culture result, rapid diagnostic test or Gram stain
- If female of childbearing potential, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study
- If male, must take appropriate measures to not get partner pregnant
- Able to comply with the protocol requirements
Exclusion Criteria
Participants will not be allowed into the study if they:
- Have received a certain amount of antibacterial therapy specific for current bacteremia unless it is demonstrated that the organism is resistant to the given antibacterial;
- Anticipate to require other antibiotics that may be potentially effective against S. aureus;
- Have shock or hypotension unresponsive to standard therapy;
- Have received an investigational product or have participated in an experimental procedure within 30 days;
- Have an intolerance or hypersensitivity to daptomycin;
- Have renal insufficiency;
- Have prior history or current evidence of muscle damage (rhabdomyolysis; significant CPK elevation);
- Have history of clinically significant muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barré or spinal cord injury;
- Have S. aureus pneumonia, empyema, meningitis, or endocarditis
Data sourced from ClinicalTrials.gov (NCT01728376) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.