RickettsiosisNCT06162975
The Surveillance Clinical Study of Rickettsiosis
An observational study of Rickettsiosis, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 24 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rickettsiosis
- How many people
- 2,000 participants
- Where
- 24 sitesRussia
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.
Who may be able to join
- 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).
Who cannot join
- Inability or unwillingness of the subject (or their legal representative) to participate in the study
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
Russia24 sites, 24 recruiting
- Recruiting
Republican Clinical Infectious Diseases Hospital
Abakan, Respublika Khakasiya, 655009
Natalia V. Kogan, +73902305324, rh_rkib@r-19.ru
- Recruiting
Abakan Interdistrict Clinical Hospital
Abakan, Respublika Khakasiya, 655017
Maria A. Ignatenko, +73902306003, amkb@r-19.ru
- Recruiting
Regional Infectious Diseases Clinical Hospital named after A.M. Nichoga
Astrakhan, Astrakhan Oblast, 414004
Anna V. Krasilova, +78512310545, krasilovaanna5@gmail.com
- Recruiting
Altai State Medical University
Barnaul, Altayskiy Kray, 656038
Nina V. Karbysheva, +73852757800, nvk80@rambler.ru
- Recruiting
City Hospital No. 5
Barnaul, Altayskiy Kray, 656045
Valeriy V. Shevchenko, +73852268417, infecgepatit@yandex.ru
- Recruiting
Barnaul Regional Clinical Hospital for Emergency Medical Care No. 2
Barnaul, Altayskiy Kray, 656050
Alexandra A. Yakimenko, +73852205333, bsmp2@zdravalt.ru
- Recruiting
Biysk Central City Hospital
Biysk, Altayskiy Kray, 659323
Larisa V. Fominskaya, +73854255169, gp1bsk@zdravalt.ru
- Recruiting
Chemal District Hospital
Chemal, Altai Republic, 649240
Olga A. Bykova, +73884123011, chemal@med04.ru
- Recruiting
Center for AIDS Prophylaxis and Treatment
Gorno-Altaysk, Altai Republic, 649002
Valentina Y. Munatova, +73882249336, Aids@med04.ru
- Recruiting
Choya District Hospital
Gusevka, Altai Republic, 649180
Anna P. Koroviakova, choyacrb@yandex.ru
- Recruiting
Irkutsk State Medical University
Irkutsk, Irkutsk Oblast, 664003
Sergei I. Malov, +73952243825, malovsergeii@mail.ru
- Recruiting
Irkutsk Regional Infectious Diseases Clinical Hospital
Irkutsk, Irkutsk Oblast, 664043
Sergei I. Malov, +73952303848, malovsergeii@mail.ru
- Recruiting
City Clinical Hospital named after Professor A.M. Voyno-Yasenetsky
Khabarovsk, Khabarovskiy Kray, 680035
Anna V. Kuznetsova, +74212358717, avkuznecova@bk.ru
- Recruiting
Kosh-Agach District Hospital
Kosh-Agach, Altai Republic, 649780
Valentina Y. Munatova, +73882249336, kosh-agach@med04.ru
- Recruiting
Infectious Diseases Hospital
Kyzyl, Respublika Tyva, 667003
Chechek B. Ondar, +73942263847, Ondar.1970@list.ru
- Recruiting
Mayma District Hospital
Mayma, Altai Republic, 649100
Valentina Y. Munatova, +73884422596, maima@med04.ru
- Recruiting
Onguday District Hospital
Onguday, Altai Republic, 649440
Valentina Y. Munatova, +73884522455, vmunatova@mail.ru
- Recruiting
Imeni Lazo District Hospital
Pereyaslavka, Khabarovskiy Kray, 682910
Elena S. Smirnova, +74215421833, rb-lazo@yandex.ru
- Recruiting
Pskov Regional Infectious Diseases Clinical Hospital
Pskov, Pskov Oblast, 180016
Alexandr V. Romanov, +78112294122, pskoblinfect@zdrav.pskov.ru
- Recruiting
Sayanogorsk Interdistrict Hospital
Sayanogorsk, Respublika Khakasiya, 655602
Natalia V. Kogan, +73904222145, koganatalya@yandex.ru
- Recruiting
Ust-Kan District Hospital
Ust'-Kan, Altai Republic, 649450
Anna V. Badanova, +73884722131, alarushkinaan@mail.ru
- Recruiting
Ust-Koksa District Hospital
Ust'-Koksa, Altai Republic, 649490
Viktor N. Rakhmanov, +73884823205, bu32@yandex.ru
- Recruiting
Ulagan District Hospital
Ust'-Ulagan, Altai Republic, 649750
Valentina Y. Munatova, +73884622158, ulagan@med04.ru
- Recruiting
Yakutia Republican Clinical Hospital
Yakutsk, Sakha, 677005
Snezhana S. Sleptsova, +74112390005, sssleptsova@yandex.ru
About this study
Official title: 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.
Read the 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.
- Conditions
- Rickettsiosis
- Medical subject headings
- Rickettsia Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic identification of the rickettsia species
Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RickettsiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexey V. Kostarnoy, PhD, Principal investigator, Gamaleya Research Center of Epidemiology and Microbiology, Health Ministry of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162975
- Sponsor's protocol ID
- 01-RICK-2023
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2023
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surveillance (Non-interventional, Observational) Multicenter Clinical Study of Rickettsiosis
- ClinicalTrials.gov ID
- NCT06162975
- Acronym / sponsor ID
- 01-RICK-2023
- Conditions
- Rickettsiosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Inability or unwillingness of the subject (or their legal representative) to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic identification of the rickettsia species
Time frame: up to 4 weeks
Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Rickettsiosis
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
RecruitingPhase 2/3
Rickettsia Clearance Study
Infectious Disease, Therapeutics
Not yet recruitingObservational study
Implementation of an RT-PCR Assay for the Diagnosis of Rickettsia Spp. Infection
Infection, Rickettsia Infections
Not yet recruiting
Serological Measurement of Montpellier Professionals' Contacts with Infectious Agents Responsible for Animal-borne Diseases
Leishmaniasis, Leptospirosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexey V. Kostarnoy, PhD principal investigator
Gamaleya Research Center of Epidemiology and Microbiology, Health Ministry of the Russian Federation
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rickettsiosis, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 24 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petya G. Gancheva (+7 9689069198, gancheva87@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic identification of the rickettsia species (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.