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Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

Primary Purpose

H. Pylori Infection

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

esomeprazole plus amoxicillin

amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole

About this trial

This is an interventional treatment trial for H. Pylori Infection

Eligibility Criteria

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

Inclusion Criteria:

The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.

Exclusion Criteria:

Age < 18 years old.
The time frame was less than 6 months from the previous eradication therapy.
The previous eradication therapy included furazolidone.
Allergic to the medication.
Pregnant or lactating women.
Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy.
Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.

Sites / Locations

Zhongshan Hospital Xiamen BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-dose dual therapy group

Furazolidone-based quadruple therapy

Arm Description

esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group

furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy

Outcomes

Primary Outcome Measures

eradication rate

eradication rate of H pylori, presenting with negative results on the 13C-UBT test

Secondary Outcome Measures

frequency of the adverse events

incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.

compliance rate of the drugs

Compliance was defined as good when they had taken more than 80% of the total medication.

Full Information

NCT ID

NCT05176821

First Posted

December 14, 2021

Last Updated

August 2, 2022

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05176821

Brief Title

Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

Official Title

Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.

Detailed Description

Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies. H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

H. Pylori Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High-dose dual therapy group

Arm Type

Experimental

Arm Description

esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group

Arm Title

Furazolidone-based quadruple therapy

Arm Type

Active Comparator

Arm Description

furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy

Intervention Type

Drug

Intervention Name(s)

esomeprazole plus amoxicillin

Other Intervention Name(s)

HDDT

Intervention Description

amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days

Intervention Type

Drug

Intervention Name(s)

amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole

Other Intervention Name(s)

Intervention Description

amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days

Primary Outcome Measure Information:

Title

eradication rate

Description

eradication rate of H pylori, presenting with negative results on the 13C-UBT test

Time Frame

42 days

Secondary Outcome Measure Information:

Title

frequency of the adverse events

Description

incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.

Time Frame

42 days

Title

compliance rate of the drugs

Description

Compliance was defined as good when they had taken more than 80% of the total medication.

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole. Exclusion Criteria: Age < 18 years old. The time frame was less than 6 months from the previous eradication therapy. The previous eradication therapy included furazolidone. Allergic to the medication. Pregnant or lactating women. Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy. Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.

Central Contact Person:

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

Jie Chen, MD

Phone

8613764633539

chen.jie5@zs-hospital.sh.cn

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

Chengzhao Weng, MD

Phone

8615859253190

weng.chengzhao@zsxmhospital.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Jiang, MD

Organizational Affiliation

Xiamen branch of Zhongshan Hospital, Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Xiamen Branch

City

Xiamen

ZIP/Postal Code

86361015

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie CHEN, MD

Phone

8613764633539

chen.jie5@zs@hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data will be available to other researchers. We may balance the potential benefits and risks for each request and then provide the data that could be shared.

IPD Sharing Time Frame

The data will be available once the results have been uploaded in the PRS system and will be available for 2 years.

IPD Sharing Access Criteria

Emails could be sent to the emails below to obtain the shared data: chen.jie5@zs-hospital.sh.cn, weng.chengzhao@zsxmhospital.com

Citations:

PubMed Identifier

30807294

Citation

Yang J, Zhang Y, Fan L, Zhu YJ, Wang TY, Wang XW, Chen DF, Lan CH. Eradication Efficacy of Modified Dual Therapy Compared with Bismuth-Containing Quadruple Therapy as a First-Line Treatment of Helicobacter pylori. Am J Gastroenterol. 2019 Mar;114(3):437-445. doi: 10.14309/ajg.0000000000000132. Erratum In: Am J Gastroenterol. 2019 May;114(5):835.

Results Reference

background

PubMed Identifier

31111580

Citation

Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, Lu H. High-dose PPI-amoxicillin dual therapy with or without bismuth for first-line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019 Aug;24(4):e12596. doi: 10.1111/hel.12596. Epub 2019 May 20.

Results Reference

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Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

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