Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

NCT03139253 | Unknown Phase 4 DMC

• 1 other identifier: 2017SDU-QILU-02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antimicrobial Susceptibility Testing; Triple Therapy

Keywords

Helicobacter Pylori Infection; Antimicrobial susceptibility testing (AST); Triple Therapy

Outcome Measures

Primary Outcomes (1)

• Eradication rate of AST guided triple therapy

  3 months

Secondary Outcomes (3)

• 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

Study Arms (5)

clarithromycin susceptible

EXPERIMENTAL

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; Drug: clarithromycin; Drug: Ilaprazole

metronidazole susceptible

EXPERIMENTAL

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

Drug: amoxicillin; Drug: tinidazole; Drug: Ilaprazole

levofloxacin susceptible

EXPERIMENTAL

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

Drug: amoxicillin; Drug: levofloxacin; Drug: Ilaprazole

furazolidone susceptible

EXPERIMENTAL

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

Drug: amoxicillin; Drug: furazolidone; Drug: Ilaprazole

tetracycline susceptible

EXPERIMENTAL

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

Drug: amoxicillin; Drug: tetracycline; Drug: Ilaprazole

Interventions

amoxicillin DRUG

amoxicillin 1000 mg bid. for 14 days

clarithromycin susceptible; furazolidone susceptible; levofloxacin susceptible; metronidazole susceptible; tetracycline susceptible

clarithromycin DRUG

clarithromycin 500 mg bid. for 14 days.

clarithromycin susceptible

tinidazole DRUG

tinidazole 500 mg bid. for 14 days.

metronidazole susceptible

levofloxacin DRUG

levofloxacin 500 mg qd. for 14 days.

levofloxacin susceptible

furazolidone DRUG

furazolidone 100 mg bid. for 14 days.

furazolidone susceptible

tetracycline DRUG

tetracycline 750 mg bid. for 14 days.

tetracycline susceptible

Ilaprazole DRUG

Ilaprazole 5 mg bid. for 14 days.

clarithromycin susceptible; furazolidone susceptible; levofloxacin susceptible; metronidazole susceptible; tetracycline susceptible

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yanqing Li: lead

MeSH Terms

Interventions

Amoxicillin; Clarithromycin; Tinidazole; Levofloxacin; Furazolidone; Tetracycline; ilaprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitrofurans; Oxazolidinones; Oxazoles; Furans; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Li Yanqing, MD, PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, MD, PhD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president of Qilu Hospital

Study Record Dates

• First Submitted: April 23, 2017
• First Posted: May 3, 2017
• Study Start: May 30, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share