Phase 4 N=82 Randomized Treatment

Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)

Bacteremia

Bottom Line

View on ClinicalTrials.gov: NCT01728376 ↗

Enrolled (actual)

Serious AEs

24.7%

Results posted

Dec 2016

Primary outcome: Primary: Number of Participants With One or More Adverse Events (AEs) — 15; 6; 12; 9 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Daptomycin (Drug); Comparator (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Primary completion: Jan 2016

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	—

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01728376). 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.