Trial design and patient populations
inflammation, sCAP
INFLAMMATION
This was a post hoc analysis of clinical data from the randomized, double-blind, placebo-controlled phase II CIGMA trial conducted in hospitals in Germany, Spain and the UK (EudraCT 2010-022380-35). Adult patients (19–93 years, To compare baseline levels of cellular and soluble markers of inflammation in sCAP patients enrolled in the CIGMA trial with those of healthy subjects, data were included from a phase I study conducted in Germany involving 24 healthy adults (20–45 years) (EudraCT 2007-005855-41). This study assessed the pharmacokinetics (PK) (IgM, IgA, and IgG), safety, and tolerability of trimodulin. The PK data from this study have been reported previously [