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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: three kinds of antibiotics including amoxicillin，tetracycline, furazolidone, levofloxacin,clarithromycin,levofloxacin,tinidazole,metronidazol

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuli Zuo, MD,PhD; Phone Number: 15588818685; Email: zuoxiuli@sina.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 257000
      • Qilu hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 month
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.	6 month

Collaborators and Investigators

• Sponsor: Xiuli Zuo
• Investigators: Principal Investigator: Xiuli Zuo, MD,PhD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Anticipated): November 20, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: November 5, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Concomitant Therapy
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Alkylating Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Monoamine Oxidase Inhibitors; Antitubercular Agents; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Antitrichomonal Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular; Amoxicillin; Clarithromycin; Levofloxacin; Ofloxacin; Tinidazole; Tetracycline; Furazolidone
• Other Study ID Numbers: 2021-SDU-QILU-G010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No