Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Antimicrobial Susceptibility Testing Clinical Trial

Official title:

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03139253
• Other study ID #: 2017SDU-QILU-02
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 23, 2017
• Last updated: May 2, 2017
• Start date: May 30, 2017
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2017
• Source: Shandong University
• Contact: Li Yanqing, MD, PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Helicobacter pylori (H. pylori), which infects about 50% of the global population, has been recognized as a main risk factor of multiple gastric pathologies, especially non-cardiac gastric cancer. Strongly evidence supports that H. pylori eradication is an effective approach to reduce the incidence of those pathologies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Consecutive patients who are 18-70 years old with persistent H. pylori infection after first or second line treatment attempts.

Exclusion Criteria:

• Enable to undergo upper endoscopy;

• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;

• Known or suspected allergy to study medications;

• Taking bismuth and antibiotics in the previous four weeks, or taking proton pump inhibitor and H2-receptor blockers in the previous two weeks;

• Currently pregnant or lactating

• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Related Conditions & MeSH terms

• Antimicrobial Susceptibility Testing
• Disease Susceptibility
• Triple Therapy

Intervention

Drug:
• amoxicillin
amoxicillin 1000 mg bid. for 14 days
• clarithromycin
clarithromycin 500 mg bid. for 14 days.
• tinidazole
tinidazole 500 mg bid. for 14 days.
• levofloxacin
levofloxacin 500 mg qd. for 14 days.
• furazolidone
furazolidone 100 mg bid. for 14 days.
• tetracycline
tetracycline 750 mg bid. for 14 days.
• Ilaprazole
Ilaprazole 5 mg bid. for 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yanqing Li

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate of AST guided triple therapy		3 months
Secondary	the rate of improving dyspepsia symptoms after H. pylori eradication		3 months
Secondary	the rate of adverse events happening		3 months
Secondary	the rate of good compliance (take pills more than 90%)		3 months