Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

An Open Randomized Controlled Study of Bismuth Quadruple Therapy With Cefuroxime as Rescue Therapy for Helicobacter Pylori Infection

To observe the efficacy of cefuroxime-containing bismuth quadruple regimen in the eradication treatment of Helicobacter pylori, and to evaluate whether it can be used as a remedial treatment for Helicobacter pylori after initial or repeated treatment failure.

Study Overview

• Status: Suspended
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Classic bismuth quadruple treatment; Drug: Cefuroxime containing bismuth quadruple treatment

Detailed Description

Introducing cefuroxime into the remedy treatment of Helicobacter pylori, on the one hand, the investigators will observe whether cefuroxime can replace tetracycline like amoxicillin, on the other hand, the investigators will observe whether it can reduce the rate of adverse effects caused by tetracycline and avoid the allergy of penicillin. If the experiment is successful, it will provide an effective and safe second-line treatment for the majority of patients with failed treatment of Helicobacter pylori.

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Employees, family members, and patients with positive C13 breath test in our hospital;
• Has received one or more previous Helicobacter pylori eradication therapy (no use of cefuroxime or tetracycline), and the result is still positive by C13 breath test;
• Willing to undergo gastroscopy and HP cultivation and identification;
• Age 18-70, gender unlimited;
• Willing to participate in and cooperate with the study, and willing to sign the informed consent.

Exclusion Criteria:

• Drugs that may affect the study results, such as PPI, H2 blockers, bismuth agents, antibiotics, etc. were taken in the 4 weeks before enrollment;
• Patients with gastrointestinal malignancy tumor;
• Patients with gastrinoma;
• After gastric or esophageal surgery;
• Suffers from serious diseases of the heart, lung, kidney, liver, blood, nervous system, endocrine system or mental system;
• Patients with contraindications or previous allergic reactions to the drugs used in this study;
• Pregnant or breastfeeding women;
• Patients with other medical conditions that may increase the treatment side effects;
• Those who cannot give informed consent;
• Has participated in other drug trials within 3 months;
• Not considered suitable for participants by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Classic bismuth quadruple treatment group	Drug: Classic bismuth quadruple treatment; Classic bismuth quadruple treatment: Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Tetracycline 500mg qid po, Metronidazole 400mg tid po Treatment duration is 14 days.
Experimental: Cefuroxime containing bismuth quadruple treatment group	Drug: Cefuroxime containing bismuth quadruple treatment; Cefuroxime containing bismuth quadruple treatment: Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Cefuroxime 500mg bid po, Metronidazole 400mg tid po Treatment duration is 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of success rates after 14 days of eradicate treatment with helicobacter pylori using a bismuth quadruple regimen containing cefuroxime and a classic bismuth quadruple regimen	The comparison of eradication rate (0-100%), it is better to have a higher eradication rate.	The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days	The eradication rate of new regimen in refractory Helicobacter pylori treatment (0-100%)	A C13 UBT will be performed 1 month after treatment.
In vitro culture and drug sensitivity test of Helicobacter pylori were conducted to observe the drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole.	The drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole（0-100%）	before the treatment
Adverse effect rate and safety of cefuroxime-containing bismuth quadruple regimen and classical bismuth quadruple regimen in patients with refractory Helicobacter pylori.	questionnaire ; follow-up visit	one month after treatment.

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Study Director: Meidong Xu, ShanghaiDongfang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2023
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• 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; Gastrointestinal Agents; Anti-Bacterial Agents; Antacids; Bismuth; Cefuroxime; Cefuroxime axetil
• Other Study ID Numbers: 2020/041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Guildline in patient consent form

Drug and device information, study documents

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