Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

NCT ID: NCT03139253

Last Updated: 2017-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Antimicrobial Susceptibility Testing Triple Therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

amoxicillin

Intervention Type DRUG

amoxicillin 1000 mg bid. for 14 days

clarithromycin

Intervention Type DRUG

clarithromycin 500 mg bid. for 14 days.

Ilaprazole

Intervention Type DRUG

Ilaprazole 5 mg bid. for 14 days.

metronidazole susceptible

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tinidazole.

Group Type EXPERIMENTAL

amoxicillin

Intervention Type DRUG

amoxicillin 1000 mg bid. for 14 days

tinidazole

Intervention Type DRUG

tinidazole 500 mg bid. for 14 days.

Ilaprazole

Intervention Type DRUG

Ilaprazole 5 mg bid. for 14 days.

levofloxacin susceptible

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and levofloxacin.

Group Type EXPERIMENTAL

amoxicillin

Intervention Type DRUG

amoxicillin 1000 mg bid. for 14 days

levofloxacin

Intervention Type DRUG

levofloxacin 500 mg qd. for 14 days.

Ilaprazole

Intervention Type DRUG

Ilaprazole 5 mg bid. for 14 days.

furazolidone susceptible

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and furazolidone.

Group Type EXPERIMENTAL

amoxicillin

Intervention Type DRUG

amoxicillin 1000 mg bid. for 14 days

furazolidone

Intervention Type DRUG

furazolidone 100 mg bid. for 14 days.

Ilaprazole

Intervention Type DRUG

Ilaprazole 5 mg bid. for 14 days.

tetracycline susceptible

Patients will receive a 14-day triple therapy to eradicate H. pylori. The regimen is consist of Ilaprazole, amoxicillin and tetracycline.

Group Type EXPERIMENTAL

amoxicillin

Intervention Type DRUG

amoxicillin 1000 mg bid. for 14 days

tetracycline

Intervention Type DRUG

tetracycline 750 mg bid. for 14 days.

Ilaprazole

Intervention Type DRUG

Ilaprazole 5 mg bid. for 14 days.

Interventions

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amoxicillin

amoxicillin 1000 mg bid. for 14 days

Intervention Type DRUG

clarithromycin

clarithromycin 500 mg bid. for 14 days.

Intervention Type DRUG

tinidazole

tinidazole 500 mg bid. for 14 days.

Intervention Type DRUG

levofloxacin

levofloxacin 500 mg qd. for 14 days.

Intervention Type DRUG

furazolidone

furazolidone 100 mg bid. for 14 days.

Intervention Type DRUG

tetracycline

tetracycline 750 mg bid. for 14 days.

Intervention Type DRUG

Ilaprazole

Ilaprazole 5 mg bid. for 14 days.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yanqing Li

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Li Yanqing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Central Contacts

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Li Yanqing, MD, PhD

Role: CONTACT

86-531-82169236

Other Identifiers

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2017SDU-QILU-02

Identifier Type: -

Identifier Source: org_study_id

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