Immunoglobulin for necrotising soft tissue infections (INSTINCT): protocol for a randomised trial

Area of Science:

• Infectious Diseases
• Immunology
• Critical Care Medicine

Background:

• Necrotising soft tissue infections (NSTI) are severe, life-threatening bacterial infections.
• Intravenous immunoglobulin (IVIG) is a potential adjunctive therapy for NSTI, but evidence is limited.
• IVIG may offer benefits but also carries risks for NSTI patients.

Purpose of the Study:

• To evaluate the efficacy and safety of IVIG as a supplementary treatment for NSTI.
• To assess the impact of IVIG on patient-reported outcomes and other patient-centered measures.
• To provide robust data on IVIG use in a critically ill patient population.

Main Methods:

• The INSTINCT trial is a randomized, double-blinded, placebo-controlled study.
• Patients with NSTI are randomized 1:1 to receive either IVIG or saline placebo.
• The primary outcome is the SF-36 physical component summary score at six months.

Main Results:

• The study aims to provide the first completed trial data on IVIG for NSTI.
• It will assess various secondary outcomes including mortality, organ failure, and adverse events.
• The trial will quantify the effects of IVIG on patient recovery and long-term function.

Conclusions:

• This trial is uniquely positioned to offer definitive data on IVIG for NSTI.
• Findings will inform clinical practice regarding the use of IVIG in severe infections.
• The study addresses a critical knowledge gap for managing NSTI patients.