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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Genetic identification of the rickettsia species | Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes | up to 4 weeks |
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Inclusion Criteria:
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
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Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petya G. Gancheva | Contact | +7 9689069198 | gancheva87@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Alexey V. Kostarnoy, PhD | Gamaleya Research Center of Epidemiology and Microbiology, Health Ministry of the Russian Federation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chemal District Hospital | Recruiting | Chemal | Altai Republic | 649240 | Russia |
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| Center for AIDS Prophylaxis and Treatment | Recruiting | Gorno-Altaysk | Altai Republic | 649002 | Russia |
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| Choya District Hospital | Recruiting | Gusevka | Altai Republic | 649180 | Russia |
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| Kosh-Agach District Hospital | Recruiting | Kosh-Agach | Altai Republic | 649780 | Russia |
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| Mayma District Hospital | Recruiting | Mayma | Altai Republic | 649100 | Russia |
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| Onguday District Hospital | Recruiting | Onguday | Altai Republic | 649440 | Russia |
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| Ust-Kan District Hospital | Recruiting | Ust'-Kan | Altai Republic | 649450 | Russia |
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| Ust-Koksa District Hospital | Recruiting | Ust'-Koksa | Altai Republic | 649490 | Russia |
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| Ulagan District Hospital | Recruiting | Ust'-Ulagan | Altai Republic | 649750 | Russia |
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| Altai State Medical University | Recruiting | Barnaul | Altayskiy Kray | 656038 | Russia |
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| City Hospital No. 5 | Recruiting | Barnaul | Altayskiy Kray | 656045 | Russia |
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| Barnaul Regional Clinical Hospital for Emergency Medical Care No. 2 | Recruiting | Barnaul | Altayskiy Kray | 656050 | Russia |
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| Biysk Central City Hospital | Recruiting | Biysk | Altayskiy Kray | 659323 | Russia |
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| Regional Infectious Diseases Clinical Hospital named after A.M. Nichoga | Recruiting | Astrakhan | Astrakhan Oblast | 414004 | Russia |
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| Irkutsk State Medical University | Recruiting | Irkutsk | Irkutsk Oblast | 664003 | Russia |
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| Irkutsk Regional Infectious Diseases Clinical Hospital | Recruiting | Irkutsk | Irkutsk Oblast | 664043 | Russia |
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| City Clinical Hospital named after Professor A.M. Voyno-Yasenetsky | Recruiting | Khabarovsk | Khabarovskiy Kray | 680035 | Russia |
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| Imeni Lazo District Hospital | Recruiting | Pereyaslavka | Khabarovskiy Kray | 682910 | Russia |
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| Pskov Regional Infectious Diseases Clinical Hospital | Recruiting | Pskov | Pskov Oblast | 180016 | Russia |
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| Republican Clinical Infectious Diseases Hospital | Recruiting | Abakan | Respublika Khakasiya | 655009 | Russia |
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| Abakan Interdistrict Clinical Hospital | Recruiting | Abakan | Respublika Khakasiya | 655017 | Russia |
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| Sayanogorsk Interdistrict Hospital | Recruiting | Sayanogorsk | Respublika Khakasiya | 655602 | Russia |
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| Infectious Diseases Hospital | Recruiting | Kyzyl | Respublika Tyva | 667003 | Russia |
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| Yakutia Republican Clinical Hospital | Recruiting | Yakutsk | Sakha | 677005 | Russia |
|
| ID | Term |
|---|---|
| D012282 | Rickettsia Infections |
| ID | Term |
|---|---|
| D012288 | Rickettsiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000079426 | Vector Borne Diseases |
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