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Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
esomeprazole, amoxicillin, furazolidone，tetracycline
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Concomitant Therapy, Rescue treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-70 with persistent H. pylori infection.
  • Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report.

Exclusion Criteria:

  • Patients unable or unwilling to receive gastroscopy.
  • Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
  • Patients with gastorectomy, acute GI bleeding and advanced gastric cancer.
  • History of allergy to any of the drugs used in the study.
  • Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk.
  • Currently pregnant or lactating.
  • Severe neurologic or psychiatric disorders.
  • Alcohol abuse or drug addiction.
  • Patients with compliance lower than 90% in any previous treatment are not included.
  • Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Sites / Locations

  • Xiuli ZuoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

14d concomitant therapy

Arm Description

Patients will receive a 14-day concomitant therapy containing esomeprazole, amoxicillin, tetracycline and furazolidone.

Outcomes

Primary Outcome Measures

Eradication rates
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all the patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Secondary Outcome Measures

The rate of adverse events happening
Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
Changes of dyspepsia symptoms after Helicobacter pylori eradication
A list of dyspepsia symptoms will be recorded. Difference of dyspepsia symptoms before and after the therapy will be compared.
The rate of good compliance
Patients taken over 90% of drugs are considered to have a good compliance.

Full Information

First Posted
October 29, 2018
Last Updated
February 19, 2020
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT03726099
Brief Title
Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection
Official Title
Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate efficacy of a 14-day concomitant therapy for the third-line treatment of Helicobacter pylori infection, and whether it is safe while maintaining an ideal eradication rates.
Detailed Description
Helicobacter pylori infects half of the world's population. H.pylori eradication is an effective approach to reduce the risk of developing gastric cancer. However, eradication rates of first-line therapy decreased over years due to the rapidly increasing antibiotic resistance of H. pylori worldwide. An ideal rescue therapeutic regimen to cure refractory H.pylori infection is currently warranted. Few published paper evaluated the efficacy of 14-day furazolidone containing concomitant therapy in the third line treatment. This study aims to propose a new concomitant therapy for the patients with two or more treatment failure, and then evaluates whether adverse effects are tolerable. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Concomitant Therapy, Rescue treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
14d concomitant therapy
Arm Type
Experimental
Arm Description
Patients will receive a 14-day concomitant therapy containing esomeprazole, amoxicillin, tetracycline and furazolidone.
Intervention Type
Drug
Intervention Name(s)
esomeprazole, amoxicillin, furazolidone，tetracycline
Intervention Description
Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day concomitant therapy containing esomeprazole 40mg bid, amoxicillin 1000mg bid , furazolidone 100mg bid and tetracycline 500mg qid.
Primary Outcome Measure Information:
Title
Eradication rates
Description
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infection. The ITT analysis includes all the patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The rate of adverse events happening
Description
Common adverse events will be measured using a 8-point Likert scale, and patients rate their symptoms from 0 (none) to 8 (severe) during the treatment process.
Time Frame
6 months
Title
Changes of dyspepsia symptoms after Helicobacter pylori eradication
Description
A list of dyspepsia symptoms will be recorded. Difference of dyspepsia symptoms before and after the therapy will be compared.
Time Frame
6 months
Title
The rate of good compliance
Description
Patients taken over 90% of drugs are considered to have a good compliance.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-70 with persistent H. pylori infection. Patients failed at least three different standard eradication therapies before. Previous standard eradication therapy was defined as a 10-day or 14-day quadruple regimen designed according to Maastricht V report. Exclusion Criteria: Patients unable or unwilling to receive gastroscopy. Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks. Patients with gastorectomy, acute GI bleeding and advanced gastric cancer. History of allergy to any of the drugs used in the study. Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk. Currently pregnant or lactating. Severe neurologic or psychiatric disorders. Alcohol abuse or drug addiction. Patients with compliance lower than 90% in any previous treatment are not included. Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zuo, MD,PhD
Phone
8653182169025
Ext
8653182169025
Email
qlywc@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiuli Zuo, MD，PhD
Phone
8653182169025
Ext
8653182169025
Email
qlywc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, MD,PhD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiuli Zuo
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, PhD,MD
Phone
15588818685
Ext
053188369277
Email
zuoxiuli@sina.com
First Name & Middle Initial & Last Name & Degree
Yue Li, MD
First Name & Middle Initial & Last Name & Degree
Chaoran Ji, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of 14-day Concomitant Therapy for Helicobacter Pylori Infection

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