Tailored Therapy for Helicobacter Pylori Rescue Treatment

Phase 4

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: esomeprazole; Drug: bismuth Potassium Citrate; Drug: amoxicillin; Drug: clarithromycin; Drug: metronidazole; Drug: levofloxacin

• Registration Number: NCT03413020
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-05
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
• Previous failures of H. pylori eradication therapy and need rescue therapy
• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection

Exclusion Criteria

• Less than 18 years old
• With previous gastric surgery
• Major systemic diseases
• Pregnancy or lactation
• Allergy to any of the study drugs
• Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tailored Therapy	esomeprazole	After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.
Tailored Therapy	bismuth Potassium Citrate	After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.
Tailored Therapy	amoxicillin	After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.
Tailored Therapy	metronidazole	After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.
Tailored Therapy	clarithromycin	After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.
Tailored Therapy	levofloxacin	After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication rate	Six weeks after completion of therapy	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

Secondary Outcome Measures

Name	Time	Method
Rate of adverse effects	Within 7 days after completion of therapy	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).
Compliance rate	Within 7 days after completion of therapy	Compliance was defined as poor when they had taken less than 80% of the total medication.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China