Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Phase 4

• Conditions: Antimicrobial Susceptibility Testing; Triple Therapy
• Interventions: Drug: amoxicillin; Drug: tinidazole; Drug: clarithromycin; Drug: levofloxacin; Drug: furazolidone; Drug: tetracycline; Drug: Ilaprazole

• Registration Number: NCT03139253
• Lead Sponsor: Yanqing Li

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-23
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Study First Posted: 2017-05-03
• Last Update Posted: 2017-05-03
• Study Start: 2017-05-30
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
levofloxacin susceptible	amoxicillin	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.
metronidazole susceptible	tinidazole	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.
clarithromycin susceptible	amoxicillin	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).
clarithromycin susceptible	clarithromycin	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).
clarithromycin susceptible	Ilaprazole	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and clarithromycin. Ilaprazole 5 mg b.i.d is used as the proton pump inhibitor (PPI).
metronidazole susceptible	Ilaprazole	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.
metronidazole susceptible	amoxicillin	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.
levofloxacin susceptible	levofloxacin	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.
levofloxacin susceptible	Ilaprazole	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.
furazolidone susceptible	amoxicillin	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.
furazolidone susceptible	furazolidone	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.
tetracycline susceptible	amoxicillin	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.
furazolidone susceptible	Ilaprazole	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.
tetracycline susceptible	tetracycline	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.
tetracycline susceptible	Ilaprazole	Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.

Primary Outcome Measures

Name	Time	Method
Eradication rate of AST guided triple therapy	3 months

Secondary Outcome Measures

Name	Time	Method
the rate of good compliance (take pills more than 90%)	3 months
the rate of adverse events happening	3 months
the rate of improving dyspepsia symptoms after H. pylori eradication	3 months