Antimicrobial Susceptibility Testing Guided Therapy Versus Empirical Therapy for the Rescue Treatment of Helicobacter Pylori Infection

NCT03565484 | Unknown Phase 4 DMC

• 1 other identifier: 2017SDU-QILU-G004
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess efficacy of 14-day antimicrobial susceptibility test guided quadruple therapy for the rescue treatment of Helicobacter pylori infection, then comparing it with 14-day personal medication history guided therapy to tell which one has a better performance in both efficacy and safety.

Conditions

Helicobacter Pylori Infection

Keywords

Antimicrobial Susceptibility Testing; Rescue Therapy

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. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.

  6 months

Secondary Outcomes (1)

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

  6 months

Other Outcomes (3)

• 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

14d bismuth quadruple therapy based on susceptibility test.

Drug: susceptibility guided therapy

Personal medication history guided therapy

EXPERIMENTAL

14d bismuth quadruple therapy based on previous medication history.

Drug: personal medication history guided therapy

Salvage therapy for negative culture

OTHER

14d bismuth quadruple therapy based on previous medication history.

Drug: personal medication history guided therapy

Salvage therapy for failed eradication

OTHER

14d bismuth quadruple therapy for salvage treatment.

Drug: salvage treatment for failed eradication

Interventions

susceptibility guided therapy DRUG

Patients will take a gastroscopy and 2 biopsies will be attained from antrum and gastric body for H.pylori culture and antimicrobial susceptibility testing (AST). The susceptibility of amoxicillin, clarithromycin, metronidazole, levofloxacin, furazolidone and tetracycline will be tested.Then patients with positive culture will be treated with a 14-day quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, and two sensitive antibiotics determined by AST. Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid, tetracycline 500mg qid.

Antimicrobial susceptibility testing guided therapy

personal medication history guided therapy DRUG

Patients will be treated with a 14-day emprical tailored quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid， colloidal bismuth pectin 200mg bid and two antibiotics based on personal medication history. If the patient doesn't have levofloxacin history, he will be treated with amoxicillin 1000mg bid plus levofloxacin 500mg bid. Otherwise, he will be treated with amoxicillin 1000mg bid and furazolidone 100mg bid.

Personal medication history guided therapy; Salvage therapy for negative culture

salvage treatment for failed eradication 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 rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, tetracycline 500mg qid and furazolidone 100mg bid.

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. Patients with previous H. pylori eradication therapy for one or two times.

You may not qualify if:

• 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)

Qilu hosipital

Jinan, Shandong, 257000, China

RECRUITING

MeSH Terms

Interventions

Salvage Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xiuli Zuo, MD,PhD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD,PhD

CONTACT

15588818685; zuoxiuli@sina.com

Xiuli Zuo, MD,PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 21, 2018
• Study Start: January 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

CN (1)