Multicenter Retrospective Study on Streptobacillus Monili... | NCT06711861

Studies
Multicenter Retrospective Study on Streptobacillus Moniliformis Infections in France

NCT06711861

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Dec 2, 2024Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Streptobacillus Moniliformis Infections

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

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 16, 2024Actual

Primary Completion Date

Feb 16, 2025Estimated

Completion Date

Feb 16, 2025Estimated

First Submitted Date

Aug 21, 2024

First Submission Date that Met QC Criteria

Nov 28, 2024

First Posted Date

Dec 2, 2024Actual

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 28, 2024

Last Update Posted Date

Dec 2, 2024Actual

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

French data on Streptobacillus moniliformis infections (zoonosis transmitted by rat bites) are rare and there are no case series in the literature to date. This is a pathology presenting atypical clinical manifestations for a bacterial infection and which therefore remains underdiagnosed. Streptobacillus moniliformis infections can be fatal without appropriate antibiotic treatment. This study could improve diagnosis, develop early treatment strategies and contribute to the overall understanding of zoonotic diseases

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

20Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study of the effectiveness of antibiotic therapy initiated for the treatment of Streptobacillus moniliformis infection.	Clinical cure 15 days after the start of antibiotic therapy. This cure is based on a negative blood culture (absence of germs) performed 15 days after the start of treatment.	Negative blood culture 15 days after the start of antibiotic therapy.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Minor patient aged 1 to 17 years
Adult patient ≥18 years
Proven Streptobacillus moniliformis infection between 01/01/2007 and 31/12/2023
Subject not objecting, after being informed, to the reuse of their data for the purposes of this research
Holders of parental authority not objecting, after being informed, to the reuse of their data for the purposes of this research their child for the purposes of this research

Exclusion Criteria:

Subject and/or holder of parental authority having expressed opposition to participating in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient having Streptobacillus moniliformis infection between 01/01/2007 and 31/12/2023

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
François DANION, MD	Contact	33 3 69 55 15 88		francois.danion@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D011906	Rat-Bite Fever
D015047	Zoonoses

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided