- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04810741
Retrospective Study of Clinical Practice and Management of Imported Schistosomiasis in France (RETROBIZH)
January 12, 2023 updated by: Assistance Publique - Hôpitaux de Paris
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
532
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Le Kremlin-Bicêtre, France
- Hospital Bicêtre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients over 18 years-old with a diagnosis of schistosomiasis in France
Description
Inclusion Criteria:
- Age ≥ 18, positive schistosomiasis immunoblot and / or positive microscopy examination for schistosomiasis eggs
Exclusion Criteria:
- - patients under guardianship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe the management of patients with chronic schistosomiasis in France, in terms of diagnosis, assessment, management and follow-up.
Time Frame: 12 months
|
Draft of new clarified recommendations on the overall management of this pathology
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephane Jareguiberry, Professor, APHP
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2021
Primary Completion (Actual)
May 18, 2022
Study Completion (Actual)
May 18, 2022
Study Registration Dates
First Submitted
March 19, 2021
First Submitted That Met QC Criteria
March 19, 2021
First Posted (Actual)
March 23, 2021
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APHP201071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No sharing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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