The Surveillance Clinical Study of Rickettsiosis

The Surveillance (Non-interventional, Observational) Clinical Study of Rickettsiosis Caused by a New Genotype of Rickettsia in the Altai Republic, Russian Federation

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.

Study Overview

• Status: Recruiting
• Conditions: Rickettsiosis

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Russian Federation
  • Altai Republic
    • Gorno-Altaïsk, Altai Republic, Russian Federation, 649002
      • Recruiting
      • Altai Republic Center for HIV prophylaxis and treatment
      • Contact: Valentina Y Munatova; Phone Number: +73882249336; Email: vmunatova@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genotype the causative agents of rickettsiosis	Genotype the causative agents of rickettsiosis in biological samples (blood and swab) of patients from the Altai Republic, Russian Federation	up to 4 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: November 28, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Rickettsiaceae Infections; Rickettsia Infections
• Other Study ID Numbers: 01-RICK-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No