H Pylori Eradication Clinical Trial
— HepyséOfficial 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
| Verified date | June 2017 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
now,European 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 73.1% for the empirical treatment versus 85.5% (p <0.001) 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 b.d;.and 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.
| Status | Recruiting |
| Enrollment | 2500 |
| Est. completion date | March 2019 |
| Est. primary completion date | February 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients = 18 years - Hospitalized or out-patients referred to one of the participating centers for upper gastrointestinal endoscopy - Who did not received a previous eradication treatment - Willing to participate and signed inform consent. Finally only patients with bacteriologically documented H. pylori infection (PCR) will be included. Exclusion Criteria: - Patient having already been treated to eradicate H pylori - No affiliation to social insurance - Person under legal protection - Refusal for signing informed consent - Patient included in another trial with medication - Patient unable to take oral medication ongoing - Patient with severe life-threatening disease in the short term - Contraindication to the PPIs, amoxicillin, metronidazole, clarithromycin, levofloxacin, tetracyclin or bismuth - Patient under treatment with antibiotics or PPI without possibility of interruption for 4 weeks - Pregnant or breast-feeding woman |
| Country | Name | City | State |
|---|---|---|---|
| France | Henri Mondor Hospital | Creteil |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Eradication rate on the basis of a negative C13 - urea breath test done 6-12 weeks after the end of treatment | Eradication rates will be compared between the patients allocated to standard treatment currently recommended (quadruple concomitant treatment, control group) and patients allocated to triple therapy chosen according to the results of molecular detection of clarithromycin resistance (guided triple therapy,, test group). The breath test is recognized as a sensitive and specific test for infection with H. pylori, particularly in the context of monitoring the efficacy of treatment. It will be carried out blindly to allocated group. | at 34 month | |
| Secondary | Safety criteria will include all adverse events occurring in the two treatment groups | at 34 month |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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