Clinical trial NCT04723472: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: The duration of treatment is 14 days. A C13 UBT will be performed 1 month after treatment.
Secondary outcomes:
measure: The Success rate of cefuroxime-containing bismuth quadruple regimen in the treatment of refractory Helicobacter pylori after 14 days
timeFrame: A C13 UBT will be performed 1 month after treatment.
measure: 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.
timeFrame: before the treatment
measure: Adverse effect rate and safety of cefuroxime-containing bismuth quadruple regimen and classical bismuth quadruple regimen in patients with refractory Helicobacter pylori.
timeFrame: one month after treatment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: ShanghaiDongfang Hospital
name: Meidong Xu
role: STUDY_DIRECTOR
References: