The Surveillance Clinical Study of Rickettsiosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-11-30

Brief Summary

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The purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsiosis in biological samples of patients from the Altai Republic, Russian Federation. 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 (plasma, or serum, and/or swabs of the tick bite site) are being collected and afterwards will be analyzed for a new rickettsia type. These data will be compared to the medical history and symptoms of the patients in order to identify clinical pattern specific for the new rickettsia type. Informed consents from all patients or their legal representatives are being collecting. The study was approved by the local ethical committee.

Detailed Description

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Conditions

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Rickettsiosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Written patient's informed concent for study participation;
* Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.

Exclusion Criteria

\- Unwillingness to participate in the study by any reason.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Altai Republic Center for HIV prophylaxis and treatment

Gorno-Altaysk, Altai Republic, Russia

Site Status RECRUITING

Countries

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Russia

Facility Contacts

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Valentina Y Munatova

Role: primary

Other Identifiers

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01-RICK-2023

Identifier Type: -

Identifier Source: org_study_id