Mycobacterium w in Septic Shock by Gram Negative infections in intensive care unit: A randomized controlled pilot study (MySSGraNe Trial)

This randomized, double-blind pilot study aims to evaluate the immunomodulatory effect of Mycobacterium w (Mw, Mycobacterium indicus pranii) on vasopressor requirements in patients with septic shock due to Gram-negative infections. Sepsis remains a leading cause of ICU mortality worldwide, with immune dysregulation complicating its management. Conventional therapies targeting single inflammatory pathways have failed, whereas immunomodulators such as Mw, shown previously to enhance Th1 responses and reduce ICU stays, may offer therapeutic benefit.

The study will recruit 50 adult patients with septic shock meeting inclusion criteria, randomized equally to receive either Mw (0.3 mL intradermally for three consecutive days) plus standard care, or placebo plus standard care. The primary endpoint is vasopressor-free days at 28 days. Secondary outcomes include ventilator-free days, antibiotic duration, time-to-vasopressor withdrawal, ICU/hospital length of stay, and incidence of nosocomial infections.

Patients will undergo daily clinical and hemodynamic monitoring, SOFA scoring, and laboratory assessments (CBC, ABG, LFT, RFT, CRP, PCT, D-dimer) until day 14 and on day 28. Randomization will be computer-generated, with investigators and patients blinded. Statistical analyses will follow an intention-to-treat approach.

This pilot trial will provide preliminary evidence on the safety and efficacy of Mw as an adjunctive therapy for septic shock, potentially paving the way for larger multicenter studies.