Clinical trial designs to study antibiotic intervention in atherosclerosis

Abstract

A number of lines of evidence point toward an association of Chlamydia pneumoniae and atherosclerosis. As evidence of this association mounts, so does an interest in the possibility that antibiotic intervention could ameliorate clinical disease. But when is it justified to start a clinical trial? One first must decide whether sufficient pre-clinical data from either in vitro or animal models is available, recognizing that animal models need validation before being considered predictive. Further, a risk/benefit assessment of the safety of the specific intervention must be weighed against the morbidity and mortality of the underlying disease.