Retrospective Study of Clinical Practice and Management o... | NCT04810741

Studies
Retrospective Study of Clinical Practice and Management of Imported Schistosomiasis in France

NCT04810741

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jan 13, 2023Actual

Enrollment

532Actual

Phase

Not provided

Conditions

Schistosomiasis

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 21, 2021Actual

Primary Completion Date

May 18, 2022Actual

Completion Date

May 18, 2022Actual

First Submitted Date

Mar 19, 2021

First Submission Date that Met QC Criteria

Mar 19, 2021

First Posted Date

Mar 23, 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

Jan 12, 2023

Last Update Posted Date

Jan 13, 2023Actual

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

Detailed Description

Schistosomiasis is a major public health issue. Clinical guidelines for the management of imported schistosomiasis are heterogeneous. The objective of this study is to describe the clinical management of schistosomiasis imported cases in France, regarding diagnosis, treatment and follow-up. It is a multicentric, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, a positive western blot and / or a positive microscopy exam. Data concerning clinical presentation, biological samples, imaging, treatment and follow-up will be assessed. A descriptive analysis will be performed.

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

532Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Describe the management of patients with chronic schistosomiasis in France, in terms of diagnosis, assessment, management and follow-up.	Draft of new clarified recommendations on the overall management of this pathology	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18, positive schistosomiasis immunoblot and / or positive microscopy examination for schistosomiasis eggs

Exclusion Criteria:

- patients under guardianship

Accepts Healthy Volunteers

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

Patients over 18 years-old with a diagnosis of schistosomiasis in France

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephane Jareguiberry, Professor	APHP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
hospital BICETRE		Le Kremlin-Bicêtre			France

IPD Sharing Statement Module

Plan to Share IPD

Description

No sharing

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012552	Schistosomiasis

Ancestor Terms

ID	Term
D014201	Trematode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided