CTRI/2015/07/005961
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Sepsis due to Gram Negative InfectionHealth Condition 2: A419- Sepsis, unspecified organism
- Sponsor
- Cadila Pharmaceuticals Limited
- Enrollment
- 202
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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