In a multicenter randomized clinical trial we evaluated the efficacy of an intravenous immunoglobulin (IVIG) protocol to decrease the rate of re-infection in solid organ recipients with severe infections and secondary antibody deficiency.
Distribution: Heart 19, Lung 9, Kidney 5, Liver transplantation 3. Patients with post transplant severe infections and secondary antibody deficiency (IgG levels < 600 mg/dL) were included. IVIG protocol: Two doses of 15 grams (interval between doses 7-15 days) followed by another 3 doses of 20 grams (interval between doses 15-30 days) of a 5% IVIG product. 36 patients were randomized to receive IVIG in combination with conventional antimicrobial therapy (n=17) or conventional antimicrobial therapy alone (n=19). Specific antibodies were tested at inclusion in the clinical trial and 30-45 days after last IVIG dose (last-visit) in a subgroup of patients to assess the kinetics of humoral immunity reconstitution.
The primary outcome measure (rate of re-infection) was significantly lower in patients randomized to receive IVIG as compared with patients receiving only conventional antimicrobial therapy (37.5 vs 76.5%, chi-square test, p=0.024). Time to reach normal IgG (IgG > 750 mg/dL) was shorter in IVIG group (55±44 vs 93±42 days, p=0.06). Significantly higher levels of specific anti-cytomegalovirus, anti-clostridium difficile toxins A and B was demonstrated at last-visit in patients who received IVIG as compared with patient that were treated with antimicrobial therapy alone.
In a multicenter randomized clinical trial we have preliminarily demonstrated that IVIG is associated with a lower rate of re-infection in solid organ transplantation with severe infection and secondary antibody deficiency.