EUCTR2013-000864-28-ES进行中（未招募）1 期
A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms - N/A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 149
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Informed consent in writing from parent(s) or legally-acceptable representative(s) and, informed assent from subject (if age appropriate according to local requirements)
- •2. Male or female, 1 year to < 18 years old (subject must be randomized before 18th birthday)
- •3. Presence of AHO warranting hospitalization and IV antibacterial therapy
- •4. Presence of AHO meeting each of the following criteria (I, II, and III):
- •I. Acute onset or worsening within the 10 days before randomization of at least 2 of the following 7 clinical symptom parameters (organized into 3 general categories) such that at least 1 category will be present and if only 1 category is present it needs to be of at least moderate severity.
- •? Localized pain
- •? Point tenderness (on palpation)
- •? Inflammation
- •? Localized warmth in the affected area
- •? Localized swelling in the affected area
- •? Area of induration
- •? Limb Function
- •? Difficulty bearing weight on affected limb
- •? Motion restriction and/or loss of function in affected limb
- •II. At least 1 of the following:
- •? Radiologic imaging (magnetic resonance imaging [MRI], bone scan, x-ray, or computed tomography [CT] scan) consistent with osteomyelitis performed within 7 days before randomization (or planned to occur within 7 days after randomization). If a qualifying radiologic imaging study is inconclusive, follow-up radiologic imaging must be done to confirm the diagnosis of AHO.
- •? A positive microbiological culture from a bone biopsy or bone aspirate (if available), or blood, or presumptive evidence of gram-positive infection by Gram-stain of specimen, or positive PCR (or other rapid detection method) testing.
- •III. Presence of at least 1 of the following:
- •? CRP > 10 mg/dL
- •? Erythrocyte sedimentation rate (ESR) > 20 mm/hour
- •? Leukocytosis (> 12,000 white blood cells [WBC]/mm3), leukopenia (< 4000 WBC/mm3), or immature neutrophils [bands] (> 10% regardless of total peripheral WBC)
- •? Fever > 38°C (100.4ºF) or hypothermia < 36°C (96.8ºF)
- •5. Female subjects who have reached menarche must have a negative serum or urine pregnancy test
- •6. Female subjects who have reached menarche and are sexually active must be willing to practice sexual abstinence or dual methods of birth control (eg, condom or diaphragm with spermicidal foam or gel) during treatment and for at least 28 days after the last dose of IV study drug (if no PO switch) or PO therapy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 204
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Documented history of any hypersensitivity or allergic reaction to daptomycin, vancomycin, or any ?-lactam antibacterial agent
- •2. Diagnosis of contiguous septic arthritis associated with AHO at baseline
- •3. AHO of the spine or pelvis or AHO involving multiple locations (2 or more bones)
- •4. Chronic osteomyelitis or symptoms of osteomyelitis exceeding 14 days
- •5. 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
- •6. AHO due to a proven gram-negative organism
- •7. At risk for infection with gram-negative organisms (e.g. with enteric gram-negative organisms due to recent gastrointestinal surgery or complex urinary tract anatomy).
- •8. Presence of 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
- •9. More than 24 hours of any potentially effective IV antibacterial therapy for AHO within 96 hours before randomization. Exceptions: a) microbiological or clinical treatment failure with a nonstudy IV antibacterial therapy that was administered for at least 48 hours. Failure must be confirmed by either microbiological laboratory report or documented worsening or no improvement of clinical signs or symptoms; b) low-dose tetracycline derivative for acne (eg, doxycycline 50 mg q12h); c) Prior treatment with oral antibiotics if subject has worsening or no improvement of clinical signs and symptoms
- •10. Requirement for any potentially effective concomitant systemic antibacterial therapy for gram-positive infections
- •11. History of seizures, with the exception of well-documented febrile seizure of childhood; peripheral neuropathy
- •12. History of rhabdomyolysis (with the exception of muscle injury due to trauma)
- •13. Sickle cell anemia
- •14. Subjects in whom clinical assessments of AHO (eg, localized pain, point tenderness, localized warmth, localized swelling, induration, difficulty bearing weight, motion restriction and/or loss of function) may not be possible (eg, due to a surgical procedure resulting in non-removable cast or splint placement) during the first several days post randomization
- •15. Any condition (eg, cystic fibrosis, current septic shock) that would make the subject, in the opinion of the Investigator, unsuitable for the study (eg, would place a subject at risk or compromise the quality of the data), or evidence of immediately life-threatening disease, progressively fatal disease, or life expectancy of 6 months or less
- •16. Creatinine clearance (CrCl) < 50 mL/min/1.73 m2 as calculated using the updated Schwartz ?bedside? formula:
- •CrCl (mL/min/1.73 m2) = 0.413 × height (length) (cm) / serum creatinine (mg/dL)
- •17. Evidence of significant hepatic, hematologic, or immunologic dysfunction as defined by the following:
- •? Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper limit of normal (× ULN) or bilirubin level > 2 × ULN
- •? Neutropenia (< 500 neutrophils/mm3)
研究者
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