Comparision of Levofloxacin and Amikacin versus Piperacillin-tazobactam and Amikacin for the Treatment of Neonatal Sepsis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- hours or earlier if treating physician considers it
研究概览
简要总结
Generally, ampicillin and gentamicin are recommended as initial antibiotic regimen to treat neonatal sepsis. However, due to emerging antimicrobial resistance, it is becoming increasingly difficult to treat neonatal sepsis. This has led to the search for alternative antibiotics which are effective. It is common practice to use piperacillin-tazobactam and amikacin combination to treat neonatal sepsis. However, resistance has also been reported to this combination of antibiotics. In our unit many bacterial isolates are sensitive to levofloxacin. However, no study has been done on the comparative effectiveness and safety of piperacillin-tazobactam and amikacin versus levofloxacin and amikacin. The diagnosis pf neonatal sepsis will be considered as per EMA 2010 criteria. Sepsis work-up will include CBC, CRP, blood culture and culture from other sterile body sites whenever indicated and feasible.Other relevant investigations such as chest x-ray, ABG, renal and liver function tests, coagulogram, cranial sonography, echocardiography will be done as per need. Lumbar puncture will be done if there is strong suspicion of septic meningitis such as seizures, bulging anterior fontanelle. and altered sensorium. We generally perform LP in late onset sepsis and those with positive blood culture unless baby is otherwise well and showing good recovery. LP will delayed for 24-48 hours in hemodynamically unstable neonates. Detailed clinical and laboratory data will be recorded on a predesigned proforma. Complications will be managed as per our unit protocol. The duration of antibiotics will be 5-7 days for clinical sepsis, 10-14 days for culture positive sepsis and 21 days in case of meningitis. We generally do not repeat LP at the completion of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •The diagnosis of neonatal sepsis will be based on the presence of the following criteria, as defined by the European Medicines Agency (2010).
- •Per EMA criteria there should be at least 2 clinical and 2 laboratory signs for making a diagnosis of suspected or confirmed neonatal sepsis.
- •These criteria are as follows: Clinical symptoms (2 or more) 1.If core body temperature >38.5°C or <36°C or temperature instability.
- •2.Cardiovascular instability: Bradycardia, (heart rate <80/min),Tachycardia (heart rate >180/min),Rhythm instability,Reduced urine output (<1ml/kg/hour),Hypotension requiring volume or inotropic support,Mottled skin, Capillary refilling time >3 seconds 3.Respiratory instability: Apnea (cessation of breathing for >20 seconds),Tachypnea (respiratory rate >60/min, Increased oxygen requirement >10%, Requirement of ventilatory support 4.Petechial rash or sclerema.
- •5.Feed intolerance or poor sucking or abdominal distension.
- •6.Central nervous system:Irritability, Lethargy, Hypotonia, Seizure 7.Cellulitis or skin ulceration.
- •8.Non-specific: irritability or lethargy or hypotonia Laboratory signs (2 or more) 1.White blood cells (WBC) count <4,000/cubic mm or >20,000/cubic mm.
- •Platelet count <100,000/cubic mm 3.Immature to total neutrophil ratio >0.2
- •C-reactive protein >10 mg/L 5.Glucose intolerance confirmed at least 2 times: hyperglycemia (blood glucose >180 mg/dL or 10mmol/L) or hypoglycemia (blood glucose <45mg/dL or 2.5 mmol/L).
- •6.Metabolic acidosis: Base excess (BE) below -10 mEq/L or Serum lactate >2 mmol/L.
- •7.Chest X-ray suggestive of bronchopneumonia 8.Cerebrosinal fluid changes suggestive of septic meningitis.
排除标准
- •1.Newborns receiving prophylactic antibiotics 2.Surgical conditions and life threatening congenital malformations 3.Failure to obtain consent 4.Prior exposure of antibiotics.
结局指标
主要结局
hours or earlier if treating physician considers it
时间窗: 7 days
Treatment failure defined as a need for changing initial antibiotics regimen within 72
时间窗: 7 days
necessary in view of rapidly deteriorating clinical
时间窗: 7 days
condition of newborn or patient not cured by 7 days after enrollment.
时间窗: 7 days
次要结局
- 1. Mortality during hospitalization(2. Adverse effects of therapy)