Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

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.

Study Overview

• Status: Unknown
• Conditions: Antimicrobial Susceptibility Testing; Triple Therapy
• Intervention / Treatment: Drug: amoxicillin; Drug: clarithromycin; Drug: Ilaprazole; Drug: tinidazole; Drug: levofloxacin; Drug: furazolidone; Drug: tetracycline

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: clarithromycin susceptible; 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).	Drug: amoxicillin; amoxicillin 1000 mg bid. for 14 days; Drug: clarithromycin; clarithromycin 500 mg bid. for 14 days.; Drug: Ilaprazole; Ilaprazole 5 mg bid. for 14 days.
EXPERIMENTAL: metronidazole susceptible; Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.	Drug: amoxicillin; amoxicillin 1000 mg bid. for 14 days; Drug: Ilaprazole; Ilaprazole 5 mg bid. for 14 days.; Drug: tinidazole; tinidazole 500 mg bid. for 14 days.
EXPERIMENTAL: levofloxacin susceptible; Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.	Drug: amoxicillin; amoxicillin 1000 mg bid. for 14 days; Drug: Ilaprazole; Ilaprazole 5 mg bid. for 14 days.; Drug: levofloxacin; levofloxacin 500 mg qd. for 14 days.
EXPERIMENTAL: furazolidone susceptible; Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.	Drug: amoxicillin; amoxicillin 1000 mg bid. for 14 days; Drug: Ilaprazole; Ilaprazole 5 mg bid. for 14 days.; Drug: furazolidone; furazolidone 100 mg bid. for 14 days.
EXPERIMENTAL: tetracycline susceptible; Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.	Drug: amoxicillin; amoxicillin 1000 mg bid. for 14 days; Drug: Ilaprazole; Ilaprazole 5 mg bid. for 14 days.; Drug: tetracycline; tetracycline 750 mg bid. for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication rate of AST guided triple therapy	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yanqing Li

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 30, 2017
• Primary Completion (ANTICIPATED): June 30, 2017
• Study Completion (ANTICIPATED): June 30, 2017

Study Registration Dates

• First Submitted: April 23, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Helicobacter Pylori Infection; Triple Therapy; Antimicrobial susceptibility testing (AST)
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Tinidazole; Tetracycline; Furazolidone
• Other Study ID Numbers: 2017SDU-QILU-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No