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Bismuth Quadruple Therapy With Cefuroxime for Helicobacter Pylori Eradication Treatment

T

Tongji University

Status

Suspended

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Cefuroxime containing bismuth quadruple treatment
Drug: Classic bismuth quadruple treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT04723472
2020/041

Details and patient eligibility

About

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.

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

82 participants in 2 patient groups

Classic bismuth quadruple treatment group
Active Comparator group
Treatment:
Drug: Classic bismuth quadruple treatment
Cefuroxime containing bismuth quadruple treatment group
Experimental group
Treatment:
Drug: Cefuroxime containing bismuth quadruple treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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