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

Shandong University700 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

700

Conditions

Therapeutic Duration Helicobacter Pylori Antimicrobial Susceptibility Test Eradication

Interventions

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.

10-day triple regimen guided by ASTOTHER

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.

14-day triple regimen guided by ASTOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 9 months

Secondary Outcomes

the rate of improving dyspepsia symptoms after H. pylori eradication

Time frame: 9 months

the rate of adverse events happening

Time frame: 9 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts