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Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723472
Recruitment Status : Not yet recruiting
First Posted : January 25, 2021
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai East Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Cefuroxime containing bismuth quadruple treatment Drug: Classic bismuth quadruple treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Randomized Controlled Study of Bismuth Quadruple Therapy With Cefuroxime as Rescue Therapy for Helicobacter Pylori Infection
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment. ]
    The comparison of eradication rate (0-100%), it is better to have a higher eradication rate.


Secondary Outcome Measures :
  1. The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days [ Time Frame: A C13 UBT will be performed 1 month after treatment. ]
    The eradication rate of new regimen in refractory Helicobacter pylori treatment (0-100%)

  2. 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. [ Time Frame: before the treatment ]
    The drug resistance rate of Helicobacter pylori to cefuroxime, tetracycline and metronidazole（0-100%）

  3. Adverse effect rate and safety of cefuroxime-containing bismuth quadruple regimen and classical bismuth quadruple regimen in patients with refractory Helicobacter pylori. [ Time Frame: one month after treatment. ]
    questionnaire ; follow-up visit


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723472


Contacts
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Contact: Xinyan Zhu 862138804518 ext 12072 xinyan.zhu@tongji.edu.cn
Contact: Fei Xu 862138804518 ext 12072 sophiayouyou@sina.com

Locations
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China, Shanghai
Shanghai East Hospital
Shanghai, Shanghai, China, 200120
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Study Director: Meidong Xu ShanghaiDongfang Hospital
More Information
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04723472    
Other Study ID Numbers: 2020/041
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Guildline in patient consent form

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Cefuroxime
Cefuroxime axetil
 Bismuth
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Anti-Bacterial Agents
Anti-Infective Agents