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Published on: November 6, 2020
Efficacy and Safety of Injection Sepsivac® (Heat-killed Mycobacterium W) in Gram-negative Sepsis administered via an
1Department of Critical Care Medicine, Fortis Escorts Heart Institute, Delhi, India; Corresponding Author.
Background:
As an immunomodulator, the mycobacterium w (Mw) has improved outcomes for patients suffering from severe sepsis. The traditional route of administration for Mw is intradermal (ID), which is limited to administering 0.1 mL per injection (Inj). The intravenous (IV) route can be an alternative to ID.
Aims And Objectives:
To evaluate the safety and efficacy of Inj Sepsivac® IV in gram-negative sepsis.
Materials And Methods:
Present retrospective observational study was conducted in an intensive care unit (ICU) of tertiary care hospital. The study included 30 consecutive patients with presumed gram-negative sepsis within 48 hours of the first organ dysfunction. Patients received Inj Sepsivac® 0.3 mL diluted in 100 mL normal saline to be given as slow IV infusions over at least 15 minutes, every day for 3 consecutive days. Efficacy was assessed by recording the change in vital parameters, sequential organ failure assessment (SOFA) score, and laboratory investigations. Safety was evaluated by the occurrence of allergic reactions including anaphylaxis, the site of infection, and secondary infection. Each patient was followed up for 14 days from the day of enrolment.
Results:
Mean age of patients with gram-negative sepsis was 62.67 ± 12.77 years with male preponderance (63.3%). Pneumonia (40.1%) and intraabdominal infections (26.7%) were the most common etiologies of sepsis. A significant improvement in all the vitals and mean SOFA scores was observed from day 2 onward. More than half of the patients required ventilator support [17 (56.7%)], and mortality was observed in 7 (25%) patients. None was reported to have a secondary infection. Laboratory parameters improved and oxygen requirement was reduced postday 4 till the end of treatment from baseline.
Conclusion:
The IV route of administration was found to be efficacious and safe and allow ease of administration in treating gram-negative sepsis. Further large multicentric randomized trials are required to confirm our findings.
Insights
Intravenous Sepsivac® (Mw) is safe and effective for treating gram-negative sepsis, improving patient vitals and organ function. This study suggests the intravenous route offers an easier administration method compared to traditional intradermal injections.
Area of Science:
- Immunology
- Critical Care Medicine
- Pharmacology
Background:
- Mycobacterium w (Mw) acts as an immunomodulator, showing promise in severe sepsis management.
- Traditional intradermal administration of Mw is limited by dosage volume.
- Intravenous (IV) administration presents a potential alternative route for Mw.
Purpose of the Study:
- To assess the safety and efficacy of intravenous Sepsivac® in patients with gram-negative sepsis.
- To evaluate the feasibility of IV administration as an alternative to intradermal injections.
Main Methods:
- Retrospective observational study in an ICU setting.
- Included 30 patients with gram-negative sepsis within 48 hours of organ dysfunction.
- Administered 0.3 mL Sepsivac® in 100 mL saline via slow IV infusion over 3 days.
Main Results:
- Significant improvement in vital signs and Sequential Organ Failure Assessment (SOFA) scores observed from day 2.
- Common etiologies included pneumonia and intraabdominal infections.
- Reduced oxygen requirements and improved laboratory parameters noted post-day 4; 25% mortality rate.
Conclusions:
- Intravenous Sepsivac® demonstrated efficacy and safety in treating gram-negative sepsis.
- The IV route facilitates easier administration.
- Further large-scale randomized trials are recommended to validate these findings.
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