Optimal Duration of Antimicrobial Susceptibility Test (AST) Guided Rescue Therapy for Helicobacter Pylori Infection

Study Overview
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Brief Summary
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Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies. However, due to the increasing resistance rates to antibiotics, failures of H. pylori eradication get more and more common. Thus, rescue therapy for persistent H. pylori infection is becoming a grand challenge the investigators have to face.

Conditions
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Therapeutic Duration, Helicobacter Pylori, Antimicrobial Susceptibility Test, Eradication

Intervention / Treatment
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* Other: 7-day triple regimen guided by AST
* Other: 10-day triple regimen guided by AST
* Other: 14-day triple regimen guided by AST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts. Exclusion Criteria: Age younger than 18 years; Patients with gastrectomy, acute GI bleeding and advanced gastric cancer; Known or suspected allergy to study medications; Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 7-day triple regimen<br>Patients in this group received a 7-day triple regimen to eradicate H. pylori. The triple therapy contains proton pump inhibitor (PPI)-clarithromycin plus a susceptible antibiotics will be involved in the study. | Other: 7-day triple regimen guided by AST<br>* Patients in this group will receive a 7-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.<br>|
| Experimental: 10-day triple regimen<br>Patients in this group received a 10-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study. | Other: 10-day triple regimen guided by AST<br>* Patients in this group will receive a 10-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.<br>|
| Experimental: 14-day triple regimen<br>Patients in this group received a 14-day triple regimen to eradicate H. pylori. The triple therapy contains PPI-clarithromycin plus a susceptible antibiotics will be involved in the study. | Other: 14-day triple regimen guided by AST<br>* Patients in this group will receive a 14-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in intention-to-treat (ITT) analysis. |  | 9 months | 
| The different rate of H. pylori eradication among 3 different course of treatments (7-day, 10-day and 14-day) guided by AST in per-protocol (PP) analysis. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of improving dyspepsia symptoms after H. pylori eradication |  | 9 months | 
| the rate of adverse events happening |  | 9 months |