The Surveillance Clinical Study of Rickettsiosis
The Surveillance (Non-interventional, Observational) Multicenter Clinical Study of Rickettsiosis
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
2,000 participants
Apr 1, 2023
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- To be included in the study, the subject must meet all the following criteria:
- Written informed consent by the subject (or their legal representative) to participate in the study;
- Men and women of any age, including children, who:
- have sought medical care (outpatient or inpatient) with suspected or diagnosed rickettsiosis; or have sought medical care (inpatient) with a history of tick bites and elevated body temperature (at least 37.2 °C lasting at least 48 hours).
Exclusion Criteria1
- \- Inability or unwillingness of the subject (or their legal representative) to participate in the study
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Locations(24)
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NCT06162975