Ignite Creation Date:
2024-05-06 @ 7:39 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02576236
Status:
UNKNOWN
Last Update Posted:
2017-07-05
First Post:
2015-09-30
Brief Title:
Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Comparison of the Efficacy and Tolerance of Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance WITH Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection a Randomised Multicentre Trial
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
RECRUITING
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:
Hepysé
Brief Summary:
The H pylori infection remains a public health problem The eradication rate with the first line triple therapy PPI-amoxicillin-clarithromycin is insufficient estimated at 70 due to the frequency of resistance to clarithromycin which reaches 21 in France Until nowEuropean and French consensus recomended tofavor sequential therapy 5 days PPI-amoxicillin and 5 days PPI-clarithromycin-metronidazole or quadruple bismuth therapy 10 days PPI-tetracyclin-metronidazole- bismuth Studies in countries with low prevalence of clarithromycin resistance reported eradication rate of 85 with sequential therapy and reported a low impact of clarithromycin resistance on the effectiveness of this treatment However recent studies suggest a greater impact of clarithromycin resistance Recent meta-analysis shows that empiric sequential therapy is less efficacious than concomitant quadruple therapy Therefore recent Maastricht V Florence meeting October 7-8 2015 recommended to abandon sequential therapy and to favor 14 days concomitant therapy in first line in order to reach an eradication rate 90
In a multicenter randomized clinical trial HELICOSTIC 2010-2011 AO ICST 2009 we compared a triple therapy guided by the results of a PCR test that detects resistance to clarithromycin and levofloxacin HelicoDR to empirical triple therapy PPI-amoxicillin-clarithromycin 1384 patients and among them 526 infected patients were enrolled in 10 centers The results in 415 patients were 731 for the empirical treatment versus 855 p 0001 for the treatment guided by PCR HelicoDR This study also demonstrated the limits of the test HelicoDR onerous possibility of contamination little practical contribution of the determination of resistance to quinolones
Moreover it has been shown that triple therapy efficiency could be optimized by increasing duration up to 14 days and increasing dose of PPI to 40mg bdand eradications rates 90 were reported with susceptible to clarithromycin strains
Adverse events are less common with optimized triple therapy than with concomitant quadruple therapy
The main objective is to compare the efficacy of optimized triple therapy guided by the results of a PCR test eradication rates 90 hypothesized with quadruple concomitant therapy eradication rate 90 hypothesized
The secondary objective is to determine side effects of optimized guided triple therapy as well as the quadruple concomitant therapy in France
In a multicenter randomized clinical trial HELICOSTIC 2010-2011 AO ICST 2009 we compared a triple therapy guided by the results of a PCR test that detects resistance to clarithromycin and levofloxacin HelicoDR to empirical triple therapy PPI-amoxicillin-clarithromycin 1384 patients and among them 526 infected patients were enrolled in 10 centers The results in 415 patients were 731 for the empirical treatment versus 855 p 0001 for the treatment guided by PCR HelicoDR This study also demonstrated the limits of the test HelicoDR onerous possibility of contamination little practical contribution of the determination of resistance to quinolones
Moreover it has been shown that triple therapy efficiency could be optimized by increasing duration up to 14 days and increasing dose of PPI to 40mg bdand eradications rates 90 were reported with susceptible to clarithromycin strains
Adverse events are less common with optimized triple therapy than with concomitant quadruple therapy
The main objective is to compare the efficacy of optimized triple therapy guided by the results of a PCR test eradication rates 90 hypothesized with quadruple concomitant therapy eradication rate 90 hypothesized
The secondary objective is to determine side effects of optimized guided triple therapy as well as the quadruple concomitant therapy in France
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-A00457-42 | OTHER | IDRCB | None |