The Surveillance Clinical Study of Rickettsiosis

Recruiting now

Conditions studied: Rickettsiosis

In brief

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.

Key facts

Study ID

NCT06162975

Run by

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

People needed

2000

Starts

2023-04-01

Expected to finish

2026-12-31

Last updated by the study team

2026-02-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Inability or unwillingness of the subject (or their legal representative) to participate in the study

Where it is running

• Chemal District Hospital — Chemal, Altai Republic, Russia (enrolling)
• Center for AIDS Prophylaxis and Treatment — Gorno-Altaysk, Altai Republic, Russia (enrolling)
• Choya District Hospital — Gusevka, Altai Republic, Russia (enrolling)
• Kosh-Agach District Hospital — Kosh-Agach, Altai Republic, Russia (enrolling)
• Mayma District Hospital — Mayma, Altai Republic, Russia (enrolling)
• Onguday District Hospital — Onguday, Altai Republic, Russia (enrolling)
• Ust-Kan District Hospital — Ust'-Kan, Altai Republic, Russia (enrolling)
• Ust-Koksa District Hospital — Ust'-Koksa, Altai Republic, Russia (enrolling)
• Ulagan District Hospital — Ust'-Ulagan, Altai Republic, Russia (enrolling)
• Altai State Medical University — Barnaul, Altayskiy Kray, Russia (enrolling)
• City Hospital No. 5 — Barnaul, Altayskiy Kray, Russia (enrolling)
• Barnaul Regional Clinical Hospital for Emergency Medical Care No. 2 — Barnaul, Altayskiy Kray, Russia (enrolling)
• Biysk Central City Hospital — Biysk, Altayskiy Kray, Russia (enrolling)
• Regional Infectious Diseases Clinical Hospital named after A.M. Nichoga — Astrakhan, Astrakhan Oblast, Russia (enrolling)
• Irkutsk State Medical University — Irkutsk, Irkutsk Oblast, Russia (enrolling)
• Irkutsk Regional Infectious Diseases Clinical Hospital — Irkutsk, Irkutsk Oblast, Russia (enrolling)
• City Clinical Hospital named after Professor A.M. Voyno-Yasenetsky — Khabarovsk, Khabarovskiy Kray, Russia (enrolling)
• Imeni Lazo District Hospital — Pereyaslavka, Khabarovskiy Kray, Russia (enrolling)
• Pskov Regional Infectious Diseases Clinical Hospital — Pskov, Pskov Oblast, Russia (enrolling)
• Republican Clinical Infectious Diseases Hospital — Abakan, Respublika Khakasiya, Russia (enrolling)
• Abakan Interdistrict Clinical Hospital — Abakan, Respublika Khakasiya, Russia (enrolling)
• Sayanogorsk Interdistrict Hospital — Sayanogorsk, Respublika Khakasiya, Russia (enrolling)
• Infectious Diseases Hospital — Kyzyl, Respublika Tyva, Russia (enrolling)
• Yakutia Republican Clinical Hospital — Yakutsk, Sakha, Russia (enrolling)

Full record on ClinicalTrials.gov

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