The Surveillance Clinical Study of Rickettsiosis

NCT06162975 | Recruiting

• 1 other identifier: 01-RICK-2023
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Rickettsiosis

Outcome Measures

Primary Outcomes (1)

• Genetic identification of the rickettsia species

  Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes

  up to 4 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.

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

Sponsors & Collaborators

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

Study Sites (24)

Chemal District Hospital

Chemal, Altai Republic, 649240, Russia

RECRUITING

Center for AIDS Prophylaxis and Treatment

Gorno-Altaysk, Altai Republic, 649002, Russia

RECRUITING

Choya District Hospital

Gusevka, Altai Republic, 649180, Russia

RECRUITING

Kosh-Agach District Hospital

Kosh-Agach, Altai Republic, 649780, Russia

RECRUITING

Mayma District Hospital

Mayma, Altai Republic, 649100, Russia

RECRUITING

Onguday District Hospital

Onguday, Altai Republic, 649440, Russia

RECRUITING

Ust-Kan District Hospital

Ust'-Kan, Altai Republic, 649450, Russia

RECRUITING

Ust-Koksa District Hospital

Ust'-Koksa, Altai Republic, 649490, Russia

RECRUITING

Ulagan District Hospital

Ust'-Ulagan, Altai Republic, 649750, Russia

RECRUITING

Altai State Medical University

Barnaul, Altayskiy Kray, 656038, Russia

RECRUITING

City Hospital No. 5

Barnaul, Altayskiy Kray, 656045, Russia

RECRUITING

Barnaul Regional Clinical Hospital for Emergency Medical Care No. 2

Barnaul, Altayskiy Kray, 656050, Russia

RECRUITING

Biysk Central City Hospital

Biysk, Altayskiy Kray, 659323, Russia

RECRUITING

Regional Infectious Diseases Clinical Hospital named after A.M. Nichoga

Astrakhan, Astrakhan Oblast, 414004, Russia

RECRUITING

Irkutsk State Medical University

Irkutsk, Irkutsk Oblast, 664003, Russia

RECRUITING

Irkutsk Regional Infectious Diseases Clinical Hospital

Irkutsk, Irkutsk Oblast, 664043, Russia

RECRUITING

City Clinical Hospital named after Professor A.M. Voyno-Yasenetsky

Khabarovsk, Khabarovskiy Kray, 680035, Russia

RECRUITING

Imeni Lazo District Hospital

Pereyaslavka, Khabarovskiy Kray, 682910, Russia

RECRUITING

Pskov Regional Infectious Diseases Clinical Hospital

Pskov, Pskov Oblast, 180016, Russia

RECRUITING

Republican Clinical Infectious Diseases Hospital

Abakan, Respublika Khakasiya, 655009, Russia

RECRUITING

Abakan Interdistrict Clinical Hospital

Abakan, Respublika Khakasiya, 655017, Russia

RECRUITING

Sayanogorsk Interdistrict Hospital

Sayanogorsk, Respublika Khakasiya, 655602, Russia

RECRUITING

Infectious Diseases Hospital

Kyzyl, Respublika Tyva, 667003, Russia

RECRUITING

Yakutia Republican Clinical Hospital

Yakutsk, Sakha, 677005, Russia

RECRUITING

MeSH Terms

Conditions

Rickettsia Infections

Condition Hierarchy (Ancestors)

Rickettsiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Study Officials

• Alexey V. Kostarnoy, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petya G. Gancheva

CONTACT

+7 9689069198; gancheva87@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 8, 2023
• Study Start: April 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (24)