Genotyping rickettsiosis-causing agents in patients from the Altai Republic
The Surveillance (Non-interventional, Observational) Multicenter Clinical Study of Rickettsiosis
This study is trying to find out more about the types of germs that cause rickettsiosis in people from the Altai Republic who have been bitten by ticks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation Academic / other |
| Locations | 24 sites (Chemal, Altai Republic and 23 other locations) |
| Trial ID | NCT06162975 on ClinicalTrials.gov |
What this trial studies
This observational clinical study aims to genotype the causative agents of rickettsiosis in biological samples from patients diagnosed or suspected to have tick-borne rickettsioses in the Altai Republic, Russian Federation. The study involves collecting medical histories, disease progression, symptoms, and treatments from participants without any intervention to their routine care. Biological samples such as plasma, serum, and swabs from tick bite sites will be analyzed to identify new rickettsia types and compare these findings with clinical data to establish specific patterns. Informed consent is obtained from all participants or their legal representatives.
Who should consider this trial
Good fit: Ideal candidates include male and female patients of any age with diagnosed or suspected tick-borne rickettsioses.
Not a fit: Patients unwilling to participate in the study will not benefit from the findings.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of rickettsiosis and improve diagnostic accuracy for patients in affected regions.
How similar studies have performed: While there may be similar observational studies, this specific approach to genotyping in the Altai Republic is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: \- Inability or unwillingness of the subject (or their legal representative) to participate in the study
Where this trial is running
Chemal, Altai Republic and 23 other locations
- Chemal District Hospital — Chemal, Altai Republic, Russia (Recruiting)
- Center for AIDS Prophylaxis and Treatment — Gorno-Altaysk, Altai Republic, Russia (Recruiting)
- Choya District Hospital — Gusevka, Altai Republic, Russia (Recruiting)
- Kosh-Agach District Hospital — Kosh-Agach, Altai Republic, Russia (Recruiting)
- Mayma District Hospital — Mayma, Altai Republic, Russia (Recruiting)
- Onguday District Hospital — Onguday, Altai Republic, Russia (Recruiting)
- Ust-Kan District Hospital — Ust'-Kan, Altai Republic, Russia (Recruiting)
- Ust-Koksa District Hospital — Ust'-Koksa, Altai Republic, Russia (Recruiting)
- Ulagan District Hospital — Ust'-Ulagan, Altai Republic, Russia (Recruiting)
- Altai State Medical University — Barnaul, Altayskiy Kray, Russia (Recruiting)
- City Hospital No. 5 — Barnaul, Altayskiy Kray, Russia (Recruiting)
- Barnaul Regional Clinical Hospital for Emergency Medical Care No. 2 — Barnaul, Altayskiy Kray, Russia (Recruiting)
- Biysk Central City Hospital — Biysk, Altayskiy Kray, Russia (Recruiting)
- Regional Infectious Diseases Clinical Hospital named after A.M. Nichoga — Astrakhan, Astrakhan Oblast, Russia (Recruiting)
- Irkutsk State Medical University — Irkutsk, Irkutsk Oblast, Russia (Recruiting)
- Irkutsk Regional Infectious Diseases Clinical Hospital — Irkutsk, Irkutsk Oblast, Russia (Recruiting)
- City Clinical Hospital named after Professor A.M. Voyno-Yasenetsky — Khabarovsk, Khabarovskiy Kray, Russia (Recruiting)
- Imeni Lazo District Hospital — Pereyaslavka, Khabarovskiy Kray, Russia (Recruiting)
- Pskov Regional Infectious Diseases Clinical Hospital — Pskov, Pskov Oblast, Russia (Recruiting)
- Republican Clinical Infectious Diseases Hospital — Abakan, Respublika Khakasiya, Russia (Recruiting)
- Abakan Interdistrict Clinical Hospital — Abakan, Respublika Khakasiya, Russia (Recruiting)
- Sayanogorsk Interdistrict Hospital — Sayanogorsk, Respublika Khakasiya, Russia (Recruiting)
- Infectious Diseases Hospital — Kyzyl, Respublika Tyva, Russia (Recruiting)
- Yakutia Republican Clinical Hospital — Yakutsk, Sakha, Russia (Recruiting)
Study contacts
- Principal investigator: Alexey V. Kostarnoy, PhD — Gamaleya Research Center of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Study coordinator: Petya G. Gancheva
- Email: gancheva87@mail.ru
- Phone: +7 9689069198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.