Health Condition 1: null- Sepsis due to Gram Negative Infection Health Condition 2: A419- Sepsis, unspecified organism
Conditions
Interventions
Intervention1: MW and standard treatment of sepsis: single daily dose of 0.3 ml of Mw intra-dermal for 3 consecutive days and standard treatment of sepsis
Control Intervention1: Placebo of MW and stan
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion 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 90 beats/min; respiratory rate of >20 breaths/min or PaCO2 of 12,000 cells/mL or 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 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 intravascular coagulation; acute lung injury/ARDS; and cardiac dysfunction (echocardiography) -Septic shock: Severe sepsis and one of the following conditions: Systemic mean BP of 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 >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/
Exclusion criteria
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 10. Patients not willing to participate or not likely to complete the trial as per judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of Mw in reducing mortality of patients with sepsisTimepoint: 28 day | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the effect of Mw on recovery of organ function as assessed by daily SOFA scores Ventilator free days Time-to-vasopressor withdrawal ICU length of stay Hospital length of stay Decline in inflammatory markers (IL-1, IL-2, TNF-, CRP, etc. at admission and every 5 days till discharge/death) To assess safety/tolerability by determining the incidence of adverse events in the treatment group versus the control groupTimepoint: till 28 day or till discharge | — |
Countries
India
Contacts
Public ContactDr Arun Maseeh
CRO-Cadila Pharmaceuticals Ltd
Outcome results
None listed