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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
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,
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

  • Qilu hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

14d concomitant therapy

Arm Description

Patients will receive a 14-day concomitant therapy Option 1:Amoxicillin+Tetracycline+Furazolidone+Vonoprazan fumarate or Esomeprazole Option 2: Amoxicillin+Furazolidone+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 3: Amoxicillin+Tetracycline+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 4: Amoxicillin+Clarithromycin+Levofloxacin+Vonoprazan fumarate or Esomeprazole Three options are selected according to the actual situation.

Outcomes

Primary Outcome Measures

Eradication rates
Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis. results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. 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
At the follow-up,adverse events complained by patients will be recorded by an independent researcher#meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events.
Compliance of patients
compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.

Full Information

First Posted
July 3, 2021
Last Updated
August 4, 2021
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT04991584
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
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 4, 2021 (Anticipated)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (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
Not Applicable
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 Option 1:Amoxicillin+Tetracycline+Furazolidone+Vonoprazan fumarate or Esomeprazole Option 2: Amoxicillin+Furazolidone+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 3: Amoxicillin+Tetracycline+Levofloxacin+Vonoprazan fumarate or Esomeprazole Option 4: Amoxicillin+Clarithromycin+Levofloxacin+Vonoprazan fumarate or Esomeprazole Three options are selected according to the actual situation.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,
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.
Primary Outcome Measure Information:
Title
Eradication rates
Description
Six weeks after completion of treatment,number of patients get H.pylori eradicated will be investigated.Then eradication rate will be calculated by using intention-to-treat analysis and per-protocol analysis. results will be investigated by an independent researcher.Then eradication rate in each group will be calculated by using intention-to-treat analysis and per-protocol analysis. 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 month
Secondary Outcome Measure Information:
Title
The rate of adverse events happening
Description
At the follow-up,adverse events complained by patients will be recorded by an independent researcher#meanwhile a 8 point visual analog scale (VAS) was used to evaluate severity of adverse events.
Time Frame
6 month
Title
Compliance of patients
Description
compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good when more than 80% or less than 120% of the total pills were taken.
Time Frame
6 month

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.
Facility Information:
Facility Name
Qilu hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China

12. IPD Sharing Statement

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

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