The Surveillance Clinical Study of Rickettsiosis

The purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsioses in biological samples of patients from the regions of Russia. This is a solely observational study in the patients with diagnosed or suspected tick-borne rickettsioses, with no intervention to the routine treatment and diagnostic process. During the study the medical history, diseases progress and symptoms, as well as treatments are being registered in individual case report forms. The rests of the samples used for standard diagnostics (blood, plasma, buffy coat, or serum, and/or swab of the eschar) are being collected and afterwards analyzed for rickettsial genotypes. These data are being compared to the medical history and symptoms of the patients in order to identify clinical patterns specific for causative agents of rickettsioses. Informed consent from all patients or their legal representatives are being collecting. The study was approved by the ethical committee.

NCT Number	NCT06162975
Lead Sponsor	Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions	Rickettsiosis
Enrollment	2,000 participants
Start Date	2023-04-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-19