Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the First-line Helicobacter Pylori Eradication.

NCT03571230 | Unknown Phase 4 DMC

• 1 other identifier: 2017SDU-QILU-G003
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess efficacy of 10-day antimicrobial susceptibility test guided triple therapy for the first-line treatment of Helicobacter pylori infection, then comparing it with 14-day empirical tailored therapy to tell which one has a better performance in both efficacy and safety.

Conditions

Helicobacter Pylori Infection; Antimicrobial Susceptibility Testing

Keywords

Helicobacter Pylori Infection; Antimicrobial Susceptibility testing(AST)

Outcome Measures

Primary Outcomes (1)

• Eradication rates in 2 groups

  Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

  6 months

Secondary Outcomes (4)

• The rate of improving dyspepsia symptoms after Helicobacter pylori eradication.

  6 months

• The rate of adverse events happening

  6 months

• The rate of good compliance

  6 months

• Difference of cost per patient for each eradication achieved in two groups

  6 months

Study Arms (4)

Antimicrobial susceptibility testing guided therapy

EXPERIMENTAL

Patients in this group will receive a 10-day triple therapy for the Helicobacter pylori eradication. The regimen contains one proton pump inhibitor and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 10d 2.two sensitive antibiotics: amoxicillin 1000mg bid for 10d, clarithromycin 500mg bid for 10d, metronidazole 500mg tid for 10d, tinidazole 500mg tid for 10d, levofloxacin 500mg qd for 10d, furazolidone 100mg bid for 10d, tetracycline 750mg bid for 10d.

Drug: two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline); Drug: one proton pump inhibitor(PPI)

Empirical tailored therapy

EXPERIMENTAL

Patients in this group will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.

Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone); Drug: one proton pump inhibitor(PPI); Drug: Colloidal Bismuth Pectin

Salvage therapy for negative culture

OTHER

When the culture results are negative, patients will receive 14-day empirical tailored therapy based on personal medication history. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics based on personal medication history: amoxicillin 1000mg bid and clarithromycin 500mg bid for 14d, amoxicillin 1000mg bid and furazolidone 100mg bid for 14d.

Drug: two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone); Drug: one proton pump inhibitor(PPI); Drug: Colloidal Bismuth Pectin

Salvage therapy for failed eradication

OTHER

If patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. Drugs: 1.one proton pump inhibitor: lansoprazole 30mg bid for 14d 2.Colloidal Bismuth Pectin 200mg bid for 14d 3.two antibiotics for rescue therapy: tetracycline 750mg bid and furazolidone 100mg bid for 14d.

Drug: one proton pump inhibitor(PPI); Drug: Colloidal Bismuth Pectin; Drug: two antibiotics for failed eradication(tetracyclin,furazolidone)

Interventions

two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline) DRUG

Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.

Antimicrobial susceptibility testing guided therapy

two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone) DRUG

Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.

Empirical tailored therapy; Salvage therapy for negative culture

one proton pump inhibitor(PPI) DRUG

All the patients need this drug.

Antimicrobial susceptibility testing guided therapy; Empirical tailored therapy; Salvage therapy for failed eradication; Salvage therapy for negative culture

Colloidal Bismuth Pectin DRUG

All the patients treated with 14-day bismuth-based quadruple therapy need this drug.

Empirical tailored therapy; Salvage therapy for failed eradication; Salvage therapy for negative culture

two antibiotics for failed eradication(tetracyclin,furazolidone) DRUG

If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.

Salvage therapy for failed eradication

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-70 with H. pylori infection.

You may not qualify if:

• Patients with previous H. pylori eradication therapy;
• Patients unable or unwilling to receive gastroscopy;
• Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks;
• Patients with gastrectomy, acute GI bleeding and advanced gastric cancer;
• Patients with known or suspected allergy to study medications;
• Currently pregnant or lactating;
• Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Xiuli Zuo

Jinan, Shandong, China

Location

MeSH Terms

Interventions

Clarithromycin; Metronidazole; Tinidazole; Levofloxacin; Furazolidone; Tetracycline

Intervention Hierarchy (Ancestors)

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

Study Officials

• Xiuli Zuo, PhD,MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, PhD,MD

CONTACT

15588818685; zuoxiuli@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 27, 2018
• Study Start: July 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

CN (1)