Phase 3 N=149 Randomized Quadruple-blind Treatment

Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)

Acute Hematogenous Osteomyelitis

Bottom Line

View on ClinicalTrials.gov: NCT01922011 ↗

Enrolled (actual)

149

Serious AEs

6.2%

Results posted

Jun 2017

Primary outcome: Primary: Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories. — 77.5; 82.9 Percentage of participants — p=0.421

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Daptomycin (Drug); Vancomycin (or equivalent) (Drug); Nafcillin (or equivalent) (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Clinical Improvement in the 3 General Categories of Pain, Inflammation, and Limb Function Based on the Investigator's Overall Assessment of Severity of Each of the Symptom Categories.	77.5; 82.9	0.421
SECONDARY Percentage of Participants With Clinical Improvement Measured as a Composite End Point of Pain, Inflammation, Limb Function, Body Temperature, and C-reactive Protein at End-of IV (EOIV) Therapy Visit.	71.0; 76.5	0.467
SECONDARY Percentage of Participants With a Favorable Clinical Outcome	85.9; 91.3; 83.1; 89.9; 81.7; 87.1	0.313
SECONDARY Percentage of Participants With a Clinical Cure Categorized by Baseline Pathogen at Test of Cure	77.8; 87.2; 76.7; 88.1; 79.5; 94.6	0.230
SECONDARY Percentage of Participants With Sustained Clinical Improvement	89.1; 94.7; 87.3; 91.4	0.272
SECONDARY Percentage of Participants With a Favorable Microbiological Response Categorized by Baseline Pathogen at Test of Cure	82.2; 91.5; 81.4; 92.9; 84.6; 94.6	—

Summary

The purpose of the study is to determine whether daptomycin is effective and safe in the treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or nafcillin (or β-lactam equivalent). The primary hypothesis is that daptomycin is non-inferior compared with vancomycin (or equivalent) or nafcillin (or β-lactam equivalent) with respect to improvement in Pain, Inflammation, and Limb Function on or before study Day 5.

Eligibility Criteria

Inclusion Criteria

Obtain Informed Consent;
Be 1 year to 21 days) or osteomyelitis with complications requiring non-routine surgical treatment (i.e. sequestration).
Have major trauma, penetrating trauma (including a puncture wound of the foot), postoperative osteomyelitis, foreign body in or adjacent to affected bone or joint, or other iatrogenic bone or joint infections present at the site of infection
Have acute hematogenous osteomyelitis due to a proven gram-negative organism
Have transient tenosynovitis, juvenile rheumatoid arthritis (JRA), reactive arthritis, bony tumors, and other osteoarticular diseases suspected to be due to a nonbacterial (eg, fungal or mycobacterial) etiology
Receive more than 24 hours of effective intravenous antibacterial therapy for osteomyelitis within 96 hours before randomization unless microbiological or clinical failure is documented
Require any potentially effective concomitant systemic antibacterial therapy for gram-positive infections
Have history of seizures (except febrile seizure of childhood)
Have peripheral neuropathy
Have history of rhabdomyolysis (with the exception of muscle injury due to trauma)
Have Sickle cell anemia
Cannot be assessed clinically during the study
Have any condition (eg, cystic fibrosis, current septic shock) that would make the subject, in the opinion of the Investigator, unsuitable for the study
Have significant reduced creatinine clearance (CrCl) < 50 mL/min/1.73 m2
Have evidence of significant hepatic, hematologic, or immunologic dysfunction
Have Creatine kinase (CK) elevation ≥ 10 × ULN (upper limit of normal) without symptoms or ≥ 5 × ULN with symptoms
If female, must not be pregnant or nursing and if required by age and life style take appropriate measures to not get pregnant during the study.
Have participated in any study involving administration of an investigational agent or device or daptomycin within 30 days
Are unable or unwilling to adhere to the study-specified procedures and restrictions
Has suspected or confirmed pneumonia, empyema, meningitis, or endocarditis.

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Data sourced from ClinicalTrials.gov (NCT01922011). 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.