The Surveillance Clinical Study of Rickettsiosis

ConditionRickettsiosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent by the subject (or their legal representative) to participate in the study;

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Genetic identification of the rickettsia species

Genetic identification of the rickettsia species causing rickettsioses, including new circulating genotypes

Time frame
up to 4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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