Tailored Therapy for Helicobacter Pylori Rescue Treatment

Efficacy of Tailored for Helicobacter Pylori Rescue Treatment Based on Antimicrobial-susceptibility Testing

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: esomeprazole; Drug: bismuth Potassium Citrate; Drug: amoxicillin; Drug: clarithromycin; Drug: metronidazole; Drug: levofloxacin

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tailored Therapy; 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.

Drug: esomeprazole; proton pump inhibitor; Drug: bismuth Potassium Citrate; gastric mucosal protective drug with anti-H. pylori effect; Drug: amoxicillin; antibiotic for H. pylori eradication; Drug: clarithromycin; antibiotic for H. pylori eradication; Drug: metronidazole; antibiotic for H. pylori eradication; Drug: levofloxacin; antibiotic for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	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).	Six weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse effects	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).	Within 7 days after completion of therapy
Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication.	Within 7 days after completion of therapy

Other Outcome Measures

Outcome Measure	Time Frame
Medical cost per patient of tailored therapy	Two months after completion of therapy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• Yu L, Luo L, Long X, Liang X, Ji Y, Chen Q, Song Y, Li X, Graham DY, Lu H. Susceptibility-guided therapy for Helicobacter pylori infection treatment failures. Therap Adv Gastroenterol. 2019 Sep 9;12:1756284819874922. doi: 10.1177/1756284819874922. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 7, 2018
• Last Update Submitted That Met QC Criteria: August 5, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Tailored therapy; Rescue therapy; Antimicrobial susceptibility testing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Respiratory System Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Expectorants; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Metronidazole; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Esomeprazole; Bismuth; Potassium Citrate
• Other Study ID Numbers: rjkls2017198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No