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

NCT02934048 | Unknown Phase 4 DMC

• 1 other identifier: 2016SDU-QILU-16
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Therapeutic Duration; Helicobacter Pylori; Antimicrobial Susceptibility Test; Eradication

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• the rate of improving dyspepsia symptoms after H. pylori eradication

  9 months

• the rate of adverse events happening

  9 months

Study Arms (3)

7-day triple regimen

EXPERIMENTAL

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

10-day triple regimen

EXPERIMENTAL

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

14-day triple regimen

EXPERIMENTAL

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

Interventions

7-day triple regimen guided by AST OTHER

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.

7-day triple regimen

10-day triple regimen guided by AST OTHER

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.

10-day triple regimen

14-day triple regimen guided by AST OTHER

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.

14-day triple regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients require upper endoscopy owing to persistent H. pylori infection despite one or more treatment attempts.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Officials

• Li Yanqing, MD, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: October 9, 2016
• First Posted: October 14, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 14, 2016

Record last verified: 2016-10