Study of Febrile Syndromes After Tick Bite | NCT05090969

Studies
Study of Febrile Syndromes After Tick Bite

NCT05090969

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 1, 2021Actual

Enrollment

940Estimated

Phase

Not provided

Conditions

Febrile Syndrome

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Oct 12, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2021

Last Update Posted Date

Dec 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Febrile syndromes after tick bites can be caused by different microorganisms: bacteria (B. miyamotoi, A. phagocytophilum, R. helvetica…), parasites (Babesia spp) and viruses (TBE virus). The clinical picture is not specific but complications may appear depending on the microorganism identified (thrombosis with N. mikurensis, meningoencephalitis with B. miyamotoi and the TBE virus). Thus, in order to provide appropriate treatment and monitoring, the infection should be documented.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

940Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective search for the presence of an emerging pathogen in the cohort of patients with febrile syndrome after tick bite		Files analysed retrospectively from January 01, 2009 to August 31, 2020 will be examined]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Major subject (≥18 years old)
Subject whose sample was sent to the bacteriology laboratory for research on Anaplasma phagocytophilum between 2009 and August 2020

Exclusion criteria:

Subject having expressed his opposition to his medical data and biological resources not being reused for scientific research.
Subject under guardianship or guardianship
Subject under safeguard of justice

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major subject whose sample was sent to the bacteriology laboratory for research on Anaplasma phagocytophilum between 2009 and August 2020

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Benoit JAULHAC, MD, PhD	Contact	33 3 69 55 14 52		benoit.jaulhac@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact			said.chayer@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Benoit JAULHAC, MD, PhD	Service Laboratoire de Bactériologie - Hôpitaux Universitaires de Strasbourg	Principal Investigator
Pierre BOYER, MD	Service Laboratoire de Bactériologie - Hôpitaux Universitaires de Strasbourg

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Laboratoire de Bactériologie - Hôpitaux Universitaires de Strasbourg	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D064927	Tick Bites

Ancestor Terms

ID	Term
D001733	Bites and Stings
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided