Patients with severe Community Aquired Pneumonia (sCAP) suffer from a severe form of pneumonia and often require life support such as mechanical ventilation. An sCAP occurs when the lung-localized inflammation spreads to the body and sepsis-associated complications occur. The average mortality rate in these patients is between 30% and 50%. This makes sCAP one of the leading causes of death in Europe and the USA.

Promising results for the treatment of sCAP are reported recently by an international research team headed by Prof. Dr. Tobias Welte, Site Director of BREATH, the Hanoverian site of the German Center for Lung Research and Head of the Clinic for Pulmonology of the Hannover Medical School, has published the results of the CIGMA study on adjunctive therapy with trimodulin.

Currently, the standard treatment of sCAP is the administration of antibiotics and intensive care. It is believed that in addition to the antibiotic therapy, an additional anti-inflammatory therapy can increase the success of treatment. In previous studies, reduced IgM levels could be detected in patients with sCAP. IgM are released as the first antibodies in an infection in the primary immune system response.

Based on these findings, Professor Welte and a team of international researchers investigated a new method of sCAP in the CIGMA study. The tested active ingredient trimodulin is a polyclonal antibody preparation (IgM / IgA / IgG) and is considered a candidate for effective adjunct therapy to the current standard of therapy. In the now completed, double-blinded, multi-center Phase II study, the efficacy and safety of this drug was investigated. All 161 patients enrolled in this study needed intensive care and were mechanically ventilated.

Although the primary endpoint of the study, the reduction of ventilator-free days, was not achieved, significant findings were obtained because, although not statistically significant, total mortality could be reduced by 20%. In a post-hoc data analysis groups of patients were identified, who benefited particularly from the trimodulin administration. In the majority of these study participants, decreased IgM levels and elevated levels of inflammation (CRP) were observed. In this patient group in particular, absolute mortality was reduced from 36.6% (placebo) to as low as 11.8%.

These important findings can now be used as a starting point for planning a subsequent phase III study.

Source: Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study). Welte T. et al. Intensive Care Med. 2018 Apr;44(4):438-448. doi: 10.1007/s00134-018-5143-7. 

Text: BREATH / CD

Picture: MHH / Tom Figiel