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

Sponsor

Shandong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02934048

Collaborator

(none)

700

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Therapeutic Duration Helicobacter Pylori Antimicrobial Susceptibility Test Eradication	Other: 7-day triple regimen guided by AST Other: 10-day triple regimen guided by AST Other: 14-day triple regimen guided by AST	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

the rate of improving dyspepsia symptoms after H. pylori eradication [9 months]
the rate of adverse events happening [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shandong University

Investigators

Principal Investigator: Li Yanqing, MD, PhD, Qilu Hospital of Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanqing Li, Vice president of Qilu Hospital, Shandong University

ClinicalTrials.gov Identifier:

NCT02934048

Other Study ID Numbers:

2016SDU-QILU-16

First Posted:

Oct 14, 2016

Last Update Posted:

Oct 14, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Disease Susceptibility

Study Results

No Results Posted as of Oct 14, 2016