The Surveillance Clinical Study of Rickettsiosis

February 16, 2026 updated by: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

The Surveillance (Non-interventional, Observational) Multicenter Clinical Study of Rickettsiosis

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is an observational study with no intervention by the Sponsor or CRO in routine treatment or diagnostic process. Patient treatment strategy is not influenced by the study protocol or by the physician's intention to include the patient in the study; instead, is based on current standards of medical care for patients with rickettsioses.

The researcher (practicing physician) are being required to obtain written informed consent form (ICF) from each patient prior to inclusion. Biological sample collection are carried out using residual samples from standard diagnostics of patients who have signed an informed consent agreement. The researcher (practicing physician) start complete an individual case report form (CRF) for each patient who signed informed consent and whose biological samples have been collected.

Prior to the commencement of the study, the sponsor obtained approval from the ethics committee to conduct the study.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
    • Altai Republic
      • Chemal, Altai Republic, Russia, 649240
        • Recruiting
        • Chemal District Hospital
        • Contact:
      • Gorno-Altaysk, Altai Republic, Russia, 649002
        • Recruiting
        • Center for AIDS Prophylaxis and Treatment
        • Contact:
          • Valentina Y. Munatova
          • Phone Number: +73882249336
          • Email: Aids@med04.ru
      • Gusevka, Altai Republic, Russia, 649180
        • Recruiting
        • Choya District Hospital
        • Contact:
          • Anna P. Koroviakova
          • Phone Number: choyacrb@yandex.ru
      • Kosh-Agach, Altai Republic, Russia, 649780
        • Recruiting
        • Kosh-Agach District Hospital
        • Contact:
      • Mayma, Altai Republic, Russia, 649100
        • Recruiting
        • Mayma District Hospital
        • Contact:
          • Valentina Y. Munatova
          • Phone Number: +73884422596
          • Email: maima@med04.ru
      • Onguday, Altai Republic, Russia, 649440
        • Recruiting
        • Onguday District Hospital
        • Contact:
      • Ust'-Kan, Altai Republic, Russia, 649450
        • Recruiting
        • Ust-Kan District Hospital
        • Contact:
      • Ust'-Koksa, Altai Republic, Russia, 649490
        • Recruiting
        • Ust-Koksa District Hospital
        • Contact:
          • Viktor N. Rakhmanov
          • Phone Number: +73884823205
          • Email: bu32@yandex.ru
      • Ust'-Ulagan, Altai Republic, Russia, 649750
        • Recruiting
        • Ulagan District Hospital
        • Contact:
    • Altayskiy Kray
      • Barnaul, Altayskiy Kray, Russia, 656038
        • Recruiting
        • Altai State Medical University
        • Contact:
      • Barnaul, Altayskiy Kray, Russia, 656045
        • Recruiting
        • City Hospital No. 5
        • Contact:
      • Barnaul, Altayskiy Kray, Russia, 656050
        • Recruiting
        • Barnaul Regional Clinical Hospital for Emergency Medical Care No. 2
        • Contact:
      • Biysk, Altayskiy Kray, Russia, 659323
        • Recruiting
        • Biysk Central City Hospital
        • Contact:
    • Astrakhan Oblast
      • Astrakhan, Astrakhan Oblast, Russia, 414004
        • Recruiting
        • Regional Infectious Diseases Clinical Hospital named after A.M. Nichoga
        • Contact:
    • Irkutsk Oblast
      • Irkutsk, Irkutsk Oblast, Russia, 664003
        • Recruiting
        • Irkutsk State Medical University
        • Contact:
      • Irkutsk, Irkutsk Oblast, Russia, 664043
        • Recruiting
        • Irkutsk Regional Infectious Diseases Clinical Hospital
        • Contact:
    • Khabarovskiy Kray
      • Khabarovsk, Khabarovskiy Kray, Russia, 680035
        • Recruiting
        • City Clinical Hospital named after Professor A.M. Voyno-Yasenetsky
        • Contact:
      • Pereyaslavka, Khabarovskiy Kray, Russia, 682910
        • Recruiting
        • Imeni Lazo District Hospital
        • Contact:
    • Pskov Oblast
      • Pskov, Pskov Oblast, Russia, 180016
        • Recruiting
        • Pskov Regional Infectious Diseases Clinical Hospital
        • Contact:
    • Respublika Khakasiya
      • Abakan, Respublika Khakasiya, Russia, 655009
        • Recruiting
        • Republican Clinical Infectious Diseases Hospital
        • Contact:
      • Abakan, Respublika Khakasiya, Russia, 655017
        • Recruiting
        • Abakan Interdistrict Clinical Hospital
        • Contact:
          • Maria A. Ignatenko
          • Phone Number: +73902306003
          • Email: amkb@r-19.ru
      • Sayanogorsk, Respublika Khakasiya, Russia, 655602
        • Recruiting
        • Sayanogorsk Interdistrict Hospital
        • Contact:
    • Respublika Tyva
      • Kyzyl, Respublika Tyva, Russia, 667003
        • Recruiting
        • Infectious Diseases Hospital
        • Contact:
    • Sakha
      • Yakutsk, Sakha, Russia, 677005
        • Recruiting
        • Yakutia Republican Clinical Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic identification of the rickettsia species
Time Frame: up to 4 weeks
Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes
up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Alexey V. Kostarnoy, PhD, Gamaleya Research Center of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-RICK-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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