Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Study Overview
=================
Brief Summary
-----------------
With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Official Title
-----------------
Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Bismuth Potassium Citrate
* Drug: Amoxicillin
* Drug: Clarithromycin
* Drug: Metronidazole
* Drug: Levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease Ability and willingness to participate in the study and to sign and give informed consent confirmed H. pylori infection Exclusion Criteria: Previous H. pylori eradication therapy Less than 18 years old With history of H. pylori infection treatment With previous gastric surgery Major systemic diseases Pregnancy or lactation Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored therapy<br>After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days. | Drug: Esomeprazole<br>* proton pump inhibitor<br>Drug: Bismuth Potassium Citrate<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* antibiotic for H. pylori eradication<br>Drug: Clarithromycin<br>* antibiotic for H. pylori eradication<br>Drug: Metronidazole<br>* antibiotic for H. pylori eradication<br>Drug: Levofloxacin<br>* antibiotic for H. pylori eradication<br>|
| Active Comparator: Empiric therapy<br>give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days | Drug: Esomeprazole<br>* proton pump inhibitor<br>Drug: Bismuth Potassium Citrate<br>* Gastric mucosal protective drug with anti-H. pylori effect<br>Drug: Amoxicillin<br>* antibiotic for H. pylori eradication<br>Drug: Metronidazole<br>* antibiotic for H. pylori eradication<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects | During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as mild (transient and well tolerated), moderate (causing discomfort and partially interfering with daily activities), or severe (causing considerable interference with daily activities). The side effect score recorded was based on the most severe event. | within 7 days after completion of therapy | 
| Compliance rate | Compliance was deﬁned as poor when they had taken less than 80% of the total medication. | within 7 days after completion of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, Bismuth quadruple therapy, Tailored therapy, Empiric therapy, clarithromycin susceptibility