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

Helicobacter Pylori Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02934048
• Other study ID #: 2016SDU-QILU-16
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 9, 2016
• Last updated: October 13, 2016
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: Shandong University
• Contact: Li Yanqing, MD, PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antimicrobial Susceptibility Test
• Disease Susceptibility
• Eradication
• Helicobacter Pylori
• Therapeutic Duration

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	the rate of improving dyspepsia symptoms after H. pylori eradication		9 months	No
Secondary	the rate of adverse events happening		9 months	No