Malaria in Strasbourg University Hospital | NCT03594084

Studies
Malaria in Strasbourg University Hospital

NCT03594084

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Sep 17, 2018Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Malaria

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

Jul 2018

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

Aug 1, 2018Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Aug 2019Estimated

First Submitted Date

Jul 10, 2018

First Submission Date that Met QC Criteria

Jul 10, 2018

First Posted Date

Jul 20, 2018Actual

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

Sep 13, 2018

Last Update Posted Date

Sep 17, 2018Actual

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

The primary purpose is to describe the anamnestic, clinical, biological, and therapeutic characteristics of imported malaria in people originated from endemic areas. Indeed, clinicians have observed that people from such areas start malaria just after their arrival in France. Such observation needed to be confirmed. In addition, The investigators observed a variation in the laboratory diagnostic performance of malaria between hospital and private laboratories. Such observation also needed to be analyzed objectively

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

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Study of clinical characteristics of imported malaria in people originated from endemic areas hospitalized at Strasbourg University Hospital from 2017 to 2018.		The period from January 1st, 2017 to January 1st, 2018 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:- Patient over 18 years

Patients from birth to 18 years
Patient submitted to guardianship
Patient submitted to trusteeship
Diagnosis patients with malaria from 01/01/2017 to 01/01/2018
Patient or legal representative agree to use medical data for this research

Exclusion Criteria:

Lack of confirmation malaria diagnosis
Impossibility to inform patients
Patient who does not wish to participate in the study
Patient submitted to justice safeguarding

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

iagnosis patients with malaria from 01/01/2017 to 01/01/2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xavier ARGEMI, MD	Contact	33 3 69 55 11 87		xavier.argemi@chru-strasbourg.fr
Anne DINDOYAL, MD	Contact	33 3 69 55 11 87		anne.dindoyal@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Xavier ARGEMI, MD	University Hospital, Strasbourg, France	Study Director

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D008288	Malaria

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Browse Leaves

Not provided

Browse Branches

Not provided