CTRI/2015/07/005961已完成2 期
Randomized, Double blind, Two Arm, Comparative Controlled,Prospective Clinical Trial of Mycobacterium w in Combination withStandard Therapy versus Standard Therapy Alone in Sepsis due to GramNegative Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Any patient of severe sepsis or septic shock as defined below:
- •-Systemic Inflammatory Response Syndrome (SIRS): Two or more of the following conditions: temperature >38.5°C or <36.0°C; heart rate of >90 beats/min; respiratory rate of
- •>20 breaths/min or PaCO2 of <32 mm Hg; and WBC count of >12,000 cells/mL or <4000
- •cells/mL, or >10 percent immature (band) forms
- •-Sepsis: SIRS in response to presumed or documented infection (culture or Gram stain of
- •blood, sputum, urine, or normally sterile body fluid positive for pathogenic microorganism;
- •or focus of infection identified by visual inspection, e.g., ruptured bowel with free air or
- •bowel contents found in abdomen at surgery, wound with purulent discharge, consolidation
- •on chest radiograph).
- •-Severe sepsis: Sepsis and at least one of the following signs of organ hypoperfusion or organ
- •dysfunction: areas of mottled skin; capillary refilling of 3 s; urinary output of <0.5 mL/kg
- •for at least 1 h or renal replacement therapy; lactate >2 mmol/L; abrupt change in mental status or abnormal EEG findings; platelet count of <100,000 cells/mL or disseminated
- •intravascular coagulation; acute lung injury/ARDS; and cardiac dysfunction
- •(echocardiography)
- •-Septic shock: Severe sepsis and one of the following conditions:
- •Systemic mean BP of <60 mm Hg ( <80 mm Hg if previous hypertension) after 40 to 60
- •mL/kg saline solution, or PCWP between 12 and 20 mm Hg; and Need for dopamine of >5
- •mcg/kg/min, or norepinephrine or epinephrine of <0.25 mcg/kg/min to maintain mean BP at
- •>60 mm Hg (80 mm Hg if previous hypertension)
- •-Refractory septic shock: Need for dopamine at >15 mcg/kg/min, or nor-epinephrine or
- •epinephrine at >0.25 mcg/kg/min to maintain mean BP at >60 mm Hg (80 mm Hg if previous
- •hypertension
- •2. AND having at least one of the following:
- •-Source of Gram negative sepsis presumed to be originating from these sources
- •(gastrointestinal, hepatobiliary, genitourinary tract, pulmonary, neurological) or
- •-Documented by typical clinical signs and symptoms and confirmed by blood culture and/or
- •histology or
- •-Documented by typical clinical signs and symptoms and confirmed by CSF culture/tissue
- •culture and/or histology or
- •-Positive culture or histology confirmation or any other investigation deemed necessary must
- •be obtained at the time of enrolment and prior to the first dose of study medication
- •3. Patients and/or legally authorized representative(s), if applicable, have been fully informed and have given written informed consent. A patient unable to write and /or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.
- •4. Patients of either gender in the age range of 18-65 years
- •5. Female patients of child bearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. They must avoid becoming pregnant while receiving
- •study medication by maintaining adequate birth control practice
- •6. Patients must have sufficient venous access to permit administration of medication and <br/
排除标准
- •1. Blood culture is positive for Gram positive organism.
- •2. Patient is pregnant or nursing.
- •3. Patients whose sole diagnosis is fungal sepsis.
- •4. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication.
- •5. Patient previously enrolled into this study.
- •6. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV.
- •7. Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk.
- •8. Patients with a life expectancy judged to be less than five days from the basic disease other
- •than sepsis.
- •9. History of cardiopulmonary resuscitation for the current episode of sepsis
- •10. Patients not willing to participate or not likely to complete the trial as per judgement of the investigator.
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