Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162975
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-28
Brief Title:
The Surveillance Clinical Study of Rickettsiosis
Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology Health Ministry of the Russian Federation
Organization:
Gamaleya Research Institute of Epidemiology and Microbiology Health Ministry of the Russian Federation
Study Overview
Official Title:
The Surveillance Non-interventional Observational Clinical Study of Rickettsiosis Caused by a New Genotype of Rickettsia in the Altai Republic Russian Federation
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None