The Surveillance Clinical Study of Rickettsiosis
- Conditions
- Rickettsiosis
- Registration Number
- NCT06162975
- Lead Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Brief Summary
The purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsiosis in biological samples of patients from the Altai Republic, Russian Federation. 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 (plasma, or serum, and/or swabs of the tick bite site) are being collected and afterwards will be analyzed for a new rickettsia type. These data will be compared to the medical history and symptoms of the patients in order to identify clinical pattern specific for the new rickettsia type. Informed consents from all patients or their legal representatives are being collecting. The study was approved by the local ethical committee.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Written patient's informed concent for study participation;
- Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.
- Unwillingness to participate in the study by any reason.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Genotype the causative agents of rickettsiosis up to 4 weeks Genotype the causative agents of rickettsiosis in biological samples (blood and swab) of patients from the Altai Republic, Russian Federation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Altai Republic Center for HIV prophylaxis and treatment
🇷🇺Gorno-Altaïsk, Altai Republic, Russian Federation