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

NCT05176821 | Unknown

• 1 other identifier: JW-Hp2021
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• eradication rate

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

  42 days

Secondary Outcomes (2)

• frequency of the adverse events

  42 days

• compliance rate of the drugs

  42 days

Study Arms (2)

High-dose dual therapy group

EXPERIMENTAL

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

Drug: esomeprazole plus amoxicillin

Furazolidone-based quadruple therapy

ACTIVE COMPARATOR

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

Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole

Interventions

esomeprazole plus amoxicillin DRUG

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

Also known as: HDDT

High-dose dual therapy group

amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole DRUG

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

Also known as: FT

Furazolidone-based quadruple therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Xiamen Branch

Xiamen, 86361015, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 30807294 BACKGROUND

• 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.

  PMID: 31111580 BACKGROUND

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Furazolidone

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Furans

Study Officials

• Wei Jiang, MD

  Xiamen branch of Zhongshan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Chen, MD

CONTACT

8613764633539; chen.jie5@zs-hospital.sh.cn

Chengzhao Weng, MD

CONTACT

8615859253190; weng.chengzhao@zsxmhospital.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 4, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available once the results have been uploaded in the PRS system and will be available for 2 years.
• 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

Locations

CN (1)