Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial

With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Metronidazole; Drug: Levofloxacin; Drug: Bismuth Potassium Citrate; Drug: Clarithromycin; Drug: Esomeprazole; Drug: Amoxicillin

• Study Type: Interventional
• Enrollment (Actual): 382
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
    • Shanghai, Shanghai, China, 200001
      • Ruijin hospital, school of medicine, Shanghai jiao tong university
    • Shanghai, Shanghai, China, 200001
      • Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
    • Shanghai, Shanghai, China, 200001
      • Shanghai Tenth people's hospital, Tongji university
    • Shanghai, Shanghai, China, 200001
      • Zhongshan Hospital,Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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
• Ability and willingness to participate in the study and to sign and give informed consent
• confirmed H. pylori infection

Exclusion Criteria:

• Previous H. pylori eradication therapy
• Less than 18 years old
• With history of H. pylori infection treatment
• 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: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

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 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.	Drug: Metronidazole; antibiotic for H. pylori eradication; Drug: Levofloxacin; antibiotic for H. pylori eradication; Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Clarithromycin; antibiotic for H. pylori eradication; Drug: Esomeprazole; proton pump inhibitor; Drug: Amoxicillin; antibiotic for H. pylori eradication
Active Comparator: Empiric therapy; give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days	Drug: Metronidazole; antibiotic for H. pylori eradication; Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Esomeprazole; proton pump inhibitor; Drug: Amoxicillin; 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
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
Rate of adverse effects	During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. 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). The side effect score recorded was based on the most severe event.	within 7 days after completion of therapy

Other Outcome Measures

Outcome Measure	Time Frame
Medical cost per patient of tailored or empiric therapy	two months after completion of therapy
Ratio of medical cost to H. pylori eradication rate of each therapy	two months after completion of therapy
Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric therapy	two months after completion of therapy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Hong Lu, M.D., Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Principal Investigator: Yunwei Sun, M.D., Ruijin hospital, school of medicine, Shanghai jiao tong university; Principal Investigator: Hong Gao, M.D., Fudan University; Principal Investigator: Yan Zhao, M.D., Shanghai Tenth people's hospital, Tongji university; Principal Investigator: Gang Xu, M.D., Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Tailored therapy; Bismuth quadruple therapy; Empiric therapy; clarithromycin susceptibility
• 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: rjkls2016110

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