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

Xiuli Zuo

Status: Unknown

Conditions: Helicobacter Pylori Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05126121

2021-SDU-QILU-G010

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

14d concomitant therapy

Experimental group

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.

Treatment:

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