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The Surveillance Clinical Study of Rickettsiosis

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Enrollment target: 100 to 2000v2 Show 5 more changesShow less
    • Primary and study completion dates: Nov 30, 2023 to Dec 31, 2026
    • Primary endpoint revised
    • Study sites: 1 to 24
    • Eligibility criteria expanded, about 61 words
    • Study description expanded, about 140 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06162975
Lead Sponsor Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Conditions
(from sponsor)		 Rickettsiosis
Related terms Rickettsia Infections
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov