Phase 3
Completed N=149
Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)
Acute Hematogenous Osteomyelitis
Source: ClinicalTrials.gov NCT01922011 ↗
Enrolled (actual)
149
Serious AEs
6.2%
Results posted
Jun 2017
Primary outcomePrimary: 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
◆ Published Evidence
Established
30citations · ~5 / year
Daptomycin for Pediatric Gram-Positive Acute Hematogenous Osteomyelitis.
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.
Linked Publications
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Daptomycin for Pediatric Gram-Positive Acute Hematogenous Osteomyelitis.
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 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01922011) 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.