EUCTR2015-000203-89-EE进行中（未招募）1 期
Multi-centre, randomised, open label, phase IIb study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and infants aged less than 90 days with late onset bacterial sepsis known or suspected to be caused by Gram-positive microorganisms - Neonatal Vancomycin Trial (NeoVanc)
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
- 300
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
- 性别
- All
入选标准
- •Postnatal age less or equal to 90 days at randomisation
- •Postnatal age 72 hours and above at onset of sepsis
- •Clinical sepsis as defined by presence of any three clinical or laboratory criteria from the list below, in the 24 hours before randomisation
- •Confirmed bacterial sepsis as defined by positive culture with a Gram-positive bacterium from a normally sterile site and at least one clinical or one laboratory criterion from the list below, in the 24 hours before randomisation
- •Clinical criteria:
- •- Hyperthermia or hypothermia
- •- Hypotension or impaired peripheral perfusion or mottled skin
- •- Apnoea or increased oxygen requirement or increased requirement for ventilatory support
- •- Bradycardic episodes or tachycardia
- •- Worsening feeding intolerance or abdominal distension
- •- Lethargy or hypotonia or irritability
- •Laboratory criteria:
- •- White blood cell (WBC) count < 4 or > 20 x 10^9 cells/L
- •- Immature to total neutrophil ratio (I/T) > 0.2
- •- Platelet count < 100 x 10^9/L
- •- C-reactive protein (CRP) > 10 mg/L
- •- Glucose intolerance as defined by a blood glucose value > 180 mg/dL (> 10 mmol/L) when receiving normal glucose amounts (8 – 15 g/kg/day)
- •- Metabolic acidosis as defined by a base excess (BE) < –10 mmol/L (<–10 mEq/L) or a blood lactate value > 2 mmol/L
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •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
- •Postnatal age less or equal to 90 days at randomisation
- •Postnatal age 72 hours and above at onset of sepsis
- •Clinical sepsis as defined by presence of any three clinical or laboratory criteria from the list below, in the 24 hours before randomisation
- •Confirmed bacterial sepsis as defined by positive culture with a Gram-positive bacterium from a normally sterile site and at least one clinical or one laboratory criterion from the list below, in the 24 hours before randomisation
- •Clinical criteria:
- •- Hyperthermia or hypothermia
- •- Hypotension or impaired peripheral perfusion or mottled skin
- •- Apnoea or increased oxygen requirement or increased requirement for ventilatory support
- •- Bradycardic episodes or tachycardia
- •- Worsening feeding intolerance or abdominal distension
- •- Lethargy or hypotonia or irritability
- •Laboratory criteria:
- •- White blood cell (WBC) count < 4 or > 20 x 10^9 cells/L
- •- Immature to total neutrophil ratio (I/T) > 0.2
- •- Platelet count < 100 x 10^9/L
- •- C-reactive protein (CRP) > 10 mg/L
- •- Glucose intolerance as defined by a blood glucose value > 180 mg/dL (> 10 mmol/L) when receiving normal glucose amounts (8 – 15 g/kg/day)
- •- Metabolic acidosis as defined by a base excess (BE) < –10 mmol/L (<–10 mEq/L) or a blood lactate value > 2 mmol/L
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 300
- •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
- •Postnatal age less or equal to 90 days at randomisation
- •Postnatal age 72 hours and above at onset of sepsis
- 另有 22 项未显示
排除标准
- •- Administration of any systemic antibiotic regimen for more than 24 hours prior to randomisation, unless the change is driven by the apparent lack of efficacy of the original regimen
- •- Treatment with vancomycin for = 24 hours at any time within 7 days of randomisation
- •- Known toxicity, hypersensitivity or intolerance to vancomycin
- •- Known acute renal impairment as defined by urinary output < 0.7 ml/kg/hour for 24 hours or a creatinine value = 100 µmol/L (1.13 mg/dL)
- •- Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass
- •- Severe congenital malformations where the infant is not expected to survive for more than 3 months
- •- Patient known to have S. aureus (MSSA or MRSA) bacteraemia
- •- Patient with osteomyelitis, septic arthritis, urinary tract infection (UTI) or meningitis
- •- Patient with high suspicion of/confirmed sepsis caused by Gram-negative organisms or fungi
- •- Other situations where the treating physician considers a different empiric antibiotic regimen necessary
- •- Current participation in any other clinical study of an investigational medicinal product (IMP)
- •Post-randomisation exclusions from analysis of efficacy
- •- Any participant found to have Gram-negative or fungal sepsis, osteomyelitis, septic arthritis, urinary tract infection, meningitis or S. aureus (MSSA or MRSA) bacteraemia after randomisation will be excluded from analysis. Participants who have received at least one dose of study vancomycin will be followed up for safety. If these exclusions exceed 10% of participants recruited then there is the option to replace the excluded babies in order to maintain the integrity of the trial
- •- Administration of any systemic antibiotic regimen for more than 24 hours prior to randomisation, unless the change is driven by the apparent lack of efficacy of the original regimen
- •- Treatment with vancomycin for = 24 hours at any time within 7 days of randomisation
- •- Known toxicity, hypersensitivity or intolerance to vancomycin
- •- Known acute renal impairment as defined by urinary output < 0.7 ml/kg/hour for 24 hours or a creatinine value = 100 µmol/L (1.13 mg/dL)
- •- Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass
- •- Severe congenital malformations where the infant is not expected to survive for more than 3 months
- •- Patient known to have S. aureus (MSSA or MRSA) bacteraemia
- •- Patient with osteomyelitis, septic arthritis, urinary tract infection (UTI) or meningitis
- •- Patient with high suspicion of/confirmed sepsis caused by Gram-negative organisms or fungi
- •- Other situations where the treating physician considers a different empiric antibiotic regimen necessary
- •- Current participation in any other clinical study of an investigational medicinal product (IMP)
- •Post-randomisation exclusions from analysis of efficacy
- •- Any participant found to have Gram-negative or fungal sepsis, osteomyelitis, septic arthritis, urinary tract infection, meningitis or S. aureus (MSSA or MRSA) bacteraemia after randomisation will be excluded from analysis. Participants who have received at least one dose of study vancomycin will be followed up for safety. If these exclusions exceed 10% of participants recruited then there is the option to replace the excluded babies in order to maintain the integrity of the trial
- •- Administration of any systemic antibiotic regimen for more than 24 hours prior to randomisation, unless the change is driven by the apparent lack of efficacy of the original regimen
- •- Treatment with vancomycin for = 24 hours at any time within 7 days of randomisation
- •- Known toxicity, hypersensitivity or intolerance to vancomycin
- •- Known acute renal impairment as defined by urinary output < 0.7 ml/kg/hour for 24 hours or a creatinine value = 100 µmol/L (1.13 mg/dL)
- •- Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass
- •- Severe congenital malformations where the infant is not expected to survive for more than 3 months
- •- Patient known to have S. aureus (MSSA or MRSA) bacteraemia
- •- Patient with osteomyelitis, septic arthritis, urinary tract infection (UTI) or meningitis
- •- Patient with high suspicion of/confirmed sepsis caused by Gram-negative organisms or fungi
- •- Other situations where the treating physician considers a different empiric antibiotic regimen necessary
- •- Current participation in any other clinical study of an investigational medicinal product (IMP)
- •Post-randomisation exclusions from analysis of efficacy
- •- Any participant found to have Gram-negative or fungal sepsis, osteomyelitis, septic arthritis, urinary tract infection, meningitis or S. aureus (MSSA or MRSA) bacteraemia after randomisation will be excluded from analysis. Participants who have received at least one dose of study vancomycin will be followed up for safety. If these exclusions exceed 10% of participants recruited then there is the option to replace the excluded babies in order to maintain the integrity of the trial
研究者
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