An observational study in Rickettsiosis, sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation. Recruiting at 24 sites in Russia. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Observational
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.
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.
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation is the lead sponsor of 41 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be included in the study, the subject must meet all the following criteria:
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genetic identification of the rickettsia species
Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes
Time frame: up to 4 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Dec 2026, 44 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Rickettsia Infections
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation