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

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 Overview

• Status: Unknown
• Conditions: Helicobacter Pylori; Eradication; Therapeutic Duration; Antimicrobial Susceptibility Test
• Intervention / Treatment: Other: 7-day triple regimen guided by AST; Other: 10-day triple regimen guided by AST; Other: 14-day triple regimen guided by AST

• Study Type: Interventional
• Enrollment (Anticipated): 700
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7-day triple regimen; 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; 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.
Experimental: 10-day triple regimen; 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; 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.
Experimental: 14-day triple regimen; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: October 9, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility
• Other Study ID Numbers: 2016SDU-QILU-16