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Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

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ClinicalTrials.gov Identifier: NCT02935010
Recruitment Status : Completed
First Posted : October 17, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Amoxicillin Drug: Clarithromycin Drug: Metronidazole Drug: Levofloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment:a Randomized Clinical Trial
Actual Study Start Date : February 5, 2017
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : March 31, 2018

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: 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

Active Comparator: Empiric therapy
give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid 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: Metronidazole
antibiotic for H. pylori eradication




Primary Outcome Measures :
  1. Helicobacter pylori eradication rate [ Time Frame: 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 :
  1. Rate of adverse effects [ Time Frame: within 7 days after completion of therapy ]
    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.

  2. Compliance rate [ Time Frame: within 7 days after completion of therapy ]
    Compliance was defined as poor when they had taken less than 80% of the total medication.


Other Outcome Measures:
  1. Medical cost per patient of tailored or empiric therapy [ Time Frame: two months after completion of therapy ]
  2. Ratio of medical cost to H. pylori eradication rate of each therapy [ Time Frame: two months after completion of therapy ]
  3. Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric therapy [ Time Frame: two months after completion of therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02935010


Locations
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China, Shanghai
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
Shanghai, Shanghai, China, 200001
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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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 Documents (Full-Text)

Documents provided by Hong Lu, MD, Shanghai Jiao Tong University School of Medicine:

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Responsible Party: Hong Lu, MD, Doctor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02935010     History of Changes
Other Study ID Numbers: rjkls2016110
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hong Lu, MD, Shanghai Jiao Tong University School of Medicine:
Helicobacter pylori
Bismuth quadruple therapy
Tailored therapy
Empiric therapy
clarithromycin susceptibility
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Antibiotics, Antitubercular
Potassium Citrate
Esomeprazole
Bismuth
Citric Acid
Anti-Infective Agents
Antitubercular Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors