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

Sponsor

Xiuli Zuo (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05126121

Collaborator

(none)

Enrollment

Location

Arm

13.3

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 20, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 14d concomitant therapy Patients will receive a 14-day concomitant therapy consisting of vonoprazan and three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, clarithromycin,levofloxacin,tinidazole,metronidazole.	Drug: three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol Three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,tinidazole,metronidazol Other Names: antibiotics

Arm

Intervention/Treatment

Experimental: 14d concomitant therapy

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

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

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

Other Names:

antibiotics

Outcome Measures

Primary Outcome Measures

Eradication rates [6 month]
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 [6 month]
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 [6 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.