Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

December 9, 2019 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Antibiotic Susceptibility-based Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy: a Prospective Clinical Trial

Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 penicillin allergy who have 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:

  • Patients without penicillin allergy
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored Therapy
Medications will be adjusted according to clarithromycin，metronidazole and levofloxacin sensitivity. All drugs will be prescribed for 14 days.(1) When three of them or clarithromycin and metronidazole are sensitive, esomeprazole 20mg bid, clarithromycin 0.5g bid and metronidazole 0.4g bid will be prescribed. (2) When two of them (levofloxacin and clarithromycin or metronidazole) are sensitive, esomeprazole 20mg bid, levofloxacin 0.5g qd plus clarithromycin 0.5g bid or metronidazole 0.4g bid will be prescribed. (3) When one of them (clarithromycin or levofloxacin) is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus clarithromycin 0.5g bid or levofloxacin 0.5g qd will be prescribed.(4) When only metronidazole or none of them is sensitive, esomeprazole 20mg bid, bismuth Potassium Citrate 600mg bid, metronidazole 0.4g qid plus tetracycline 0.4g qid will be prescribed.
Drug: Esomeprazole
Proton pump inhibitor
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: Tetracycline
antibiotic for H. pylori eradication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Six weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse effects
Time Frame: 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)
Within 7 days after completion of therapy
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.
Within 7 days after completion of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Hong Lu, M.D.,Ph.D., Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

January 13, 2018

First Submitted That Met QC Criteria

October 14, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 9, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjkls2017197

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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