Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04723472
• Other study ID #: 2020/041
• Status: Suspended
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 82
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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.