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

Primary Purpose

Helicobacter Pylori Infection

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol

About this trial

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

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 treated with H2-receptor antagonist, PPI, vonoprazan,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 hosipital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

14d concomitant therapy

Arm Description

Patients will receive a 14-day concomitant therapy consisting of vonoprazan and three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, clarithromycin,levofloxacin,tinidazole,metronidazole.

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.Adverse events were graded as mild, moderate, or severe.

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

NCT ID

NCT05126121

First Posted

November 5, 2021

Last Updated

November 18, 2021

Sponsor

Xiuli Zuo

1. Study Identification

Unique Protocol Identification Number

NCT05126121

Brief Title

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

Official Title

Efficacy and Safety of 14-day Concomitant Therapy for Difficult-to-Treat Helicobacter Pylori: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 20, 2021 (Anticipated)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xiuli Zuo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

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 treatment of Hard-to-treat 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. This study aims to propose a new concomitant therapy for the patients with three 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

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

Intervention Type

Drug

Intervention Name(s)

three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol

Other Intervention Name(s)

antibiotics

Intervention Description

Three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,tinidazole,metronidazol

Primary Outcome Measure Information:

Title

Eradication rates

Description

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.Adverse events were graded as mild, moderate, or severe.

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

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 treated with H2-receptor antagonist, PPI, vonoprazan,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

15588818685

zuoxiuli@sina.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiuli Zuo, MD,PhD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiuli Zuo, MD,PhD

Organizational Affiliation

Study Principal investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qilu hosipital

City

Jinan

State/Province

Shandong

ZIP/Postal Code

257000

Country

China

12. IPD Sharing Statement

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

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