Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

NCT04723472 | Suspended

• 1 other identifier: 2020/041
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (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

  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 Outcomes (3)

• The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days

  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.

  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.

  one month after treatment.

Study Arms (2)

Classic bismuth quadruple treatment group

ACTIVE COMPARATOR

Drug: Classic bismuth quadruple treatment

Cefuroxime containing bismuth quadruple treatment group

EXPERIMENTAL

Drug: Cefuroxime containing bismuth quadruple treatment

Interventions

Cefuroxime containing bismuth quadruple treatment DRUG

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.

Cefuroxime containing bismuth quadruple treatment group

Classic bismuth quadruple treatment DRUG

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.

Classic bismuth quadruple treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Study Officials

• Meidong Xu

  ShanghaiDongfang Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: August 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)