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Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

Primary Purpose

Helicobacter Pylori Infection

Status
Suspended
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cefuroxime containing bismuth quadruple treatment
Classic bismuth quadruple treatment
Sponsored by
Shanghai East Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai East Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Classic bismuth quadruple treatment group

Cefuroxime containing bismuth quadruple treatment group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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%)
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%）
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

Full Information

First Posted
January 21, 2021
Last Updated
November 9, 2022
Sponsor
Shanghai East Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04723472
Brief Title
Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment
Official Title
An Open Randomized Controlled Study of Bismuth Quadruple Therapy With Cefuroxime as Rescue Therapy for Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Suspended
Why Stopped
Want to modify the study further
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classic bismuth quadruple treatment group
Arm Type
Active Comparator
Arm Title
Cefuroxime containing bismuth quadruple treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cefuroxime containing bismuth quadruple treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Classic bismuth quadruple treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
The comparison of eradication rate (0-100%), it is better to have a higher eradication rate.
Time Frame
The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment.
Secondary Outcome Measure Information:
Title
The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days
Description
The eradication rate of new regimen in refractory Helicobacter pylori treatment (0-100%)
Time Frame
A C13 UBT will be performed 1 month after treatment.
Title
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.
Description
The drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole（0-100%）
Time Frame
before the treatment
Title
Adverse effect rate and safety of cefuroxime-containing bismuth quadruple regimen and classical bismuth quadruple regimen in patients with refractory Helicobacter pylori.
Description
questionnaire ; follow-up visit
Time Frame
one month after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meidong Xu
Organizational Affiliation
ShanghaiDongfang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Guildline in patient consent form

Learn more about this trial

Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

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