Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05495854
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2022-08-08
Brief Title:
New Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive PCR in Stool
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Pilot Feasibility and Non-inferiority Study of a Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive Technique for the Detection of Helicobacter Pylori Infection and Clarithromycin Resistance by PCR Real Time in the Stool
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In France every year 1 million people are explored for Helicobacter pylori infection and 200000 receive eradication treatment Faced with the high prevalence of Hp resistance to antibiotics the Haute Autorité de Santé HAS has recommended since 2017 a treatment strategy guided by the results of bacteriological tests culture and antibiogram and or PCR carried out from gastric biopsies Guided therapy is more effective cheaper and better tolerated than empiric therapy it includes fewer antibiotics But the guided treatment is not used despite the recommendations because of the invasive nature of the endoscopy the difficulty of culture and the non-reimbursement of the PCR A new non-invasive test by real-time PCR performed on the stools of patients makes it possible to detect the Hp infection and its sensitivity to clarithromycin and therefore to guide the treatment with excellent performance as we have been able to demonstrate during a study including 1200 patients Pichon et al J Clin Microbiol 2020 These characteristics allow this test to be used in primary care but has to be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None