Effects of carrimycin on biomarkers of inflammation and immune function in tumor patients with sepsis: a multicenter double-blind randomized controlled trial

Abstract

Abstract Background With progress in tumor treatments, patient survival has been significantly extended; nevertheless, tumors and tumor treatments increase the risk of sepsis. Carrimycin may act as an immune-regulating treatment for tumor-related sepsis. We aimed to evaluate whether carrimycin regulates inflammation and immune function in tumor patients with sepsis. Methods We conducted a multicenter, randomized, placebo-controlled, double-blind clinical trial involving tumor patients with sepsis. The participant inclusion criteria were as follows: 1. age ≥ 18 and ≤ 75 years old; 2. condition consistent with sepsis 3.0 diagnostic criteria; 3. SOFA score of 2–13; and 4. patients with malignant tumors. Enrolled patients were assigned to either carrimycin treatment (400 mg/day) or placebo treatment (400 mg/day) orally once a day for 7 days. The primary outcome was immune-related indicators. Results A total of 120 patients were randomized, of whom 47 were assigned to receive carrimycin and 52 placebo. In immune and inflammation indicators, the HLA-DR and CD8 + T-cell levels showed promising trends, although there was no significant difference between the carrimycin and placebo groups (P > 0.05). In the CD4 < 38.25 subgroup, the HLA-DR level of the carrimycin group was significantly better than that of the placebo group at 1 day after administration (P = 0.023). In the CD8 < 25.195 subgroup, the degree of decrease in IL-8 in the carrimycin group was significantly higher than that in the placebo group at 1 (P = 0.027) and 3 (P = 0.034) days after administration. The CD8 + T-cell subset level of the carrimycin group was significantly better than that of the placebo group at 3 (P = 0.027) and 5 (P = 0.035) days after administration. The levels of SOFA, APACHE II, PCT and CRP were significantly reduced by carrimycin intervention. No serious adverse events were recorded. Conclusions In tumor patients with sepsis, especially those with immunocompromised function, carrimycin regulates the immune status by increasing the HLA-DR level and plays an anti-infective role to improve the severity of the disease but does not affect 28-day all-cause mortality. The trial was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn) with the number ChiCTR2000032339 on April 26, 2020.