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NCT Number: NCT06162975

The Surveillance 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Chemal District Hospital, Chemal, Altai Republic, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

  • Inability or unwillingness of the subject (or their legal representative) to participate in the study

Treatment and study plan

Primary outcomes

  1. Genetic identification of the rickettsia species

    Time frame: up to 4 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Petya G. Gancheva

CONTACT

[email protected]

+7 9689069198

Sponsors and collaborators

Lead sponsor

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Other

Registry information

Official study title

The Surveillance (Non-interventional, Observational) Multicenter Clinical Study of Rickettsiosis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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