Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin

NCT ID: NCT06351891

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-12-31

Brief Summary

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

14-day bismuth quadruple regimen containing cefuroxime and tetracycline

14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Tetracycline (500mg three times/day after three meals);14 days.

Group Type: EXPERIMENTAL

14-day bismuth quadruple regimen containing cefuroxime and tetracycline

Intervention Type: DRUG

14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Tetracycline 500mg tid,14 days.Evaluating the efficacy and safety of 14-Day bismuth quadruple therapy containing cefuroxime and tetracycline for Helicobacter pylori eradication.

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan (50mg twice/day before breakfast and supper), Bismuth potassium citrate capsule (0.6g twice/day before breakfast and supper), Cefuroxime tablets (500mg twice/day after breakfast and supper), Levofloxacin (500mg once/day after breakfast);14 days.

Group Type: ACTIVE_COMPARATOR

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

Intervention Type: DRUG

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Levofloxacin 500mg qd,14 days.

Interventions

14-day bismuth quadruple regimen containing cefuroxime and tetracycline

14-day bismuth quadruple regimen containing cefuroxime and tetracycline:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Tetracycline 500mg tid,14 days.Evaluating the efficacy and safety of 14-Day bismuth quadruple therapy containing cefuroxime and tetracycline for Helicobacter pylori eradication.

Intervention Type: DRUG

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

14-day bismuth quadruple regimen containing cefuroxime and levofloxacin:Tegoprazan 50mg bid, Bismuth potassium citrate capsules 0.6g bid,Cefuroxime tablets 500mg bid,Levofloxacin 500mg qd,14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-70 years old, regardless of gender.

2. History of penicillin allergy.

3. Helicobacter pylori infection.

4. Patients who have not previously received Helicobacter pylori eradication therapy.

Exclusion Criteria

1. Medication history of bismuth and antibiotics within 4 weeks; PPIs and P-CABs within 2 weeks.

2. Serious underlying diseases, such as liver insufficiency, renal insufficiency, malignant tumors, etc.

3. Previous gastric or esophageal surgery.

4. History of allergy to test drugs.

5. Pregnant and lactating women and those unwilling to use contraception during the trial period.

6. Have other behaviors that may increase the risk such as alcohol and drug abuse.

7. Those unable to provide informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yueyue Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Yueyue Li, MD,PhD

Role: CONTACT

lyynqj@126.com

86-18560089751

Facility Contacts

Yueyue Li, MD,PhD

Role: primary

lyynqj@162.com

86-18560089751

References

Wang H, Kong Q, Zhang Q, Zhang L, Li R, Zhang T, Guo L, Wang X, Li X, Zhao H, Liu F, Guo Y, Zhai Z, Li M, Yang X, Zuo X, Yang X, Li Y. Efficacy and Safety of Cefuroxime-Tetracycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Eradication in Penicillin-Allergic Patients: A Multicenter Randomized Controlled Trial. Helicobacter. 2025 Mar-Apr;30(2):e70033. doi: 10.1111/hel.70033.

Reference Type: DERIVED

PMID: 40237213 (View on PubMed)

Other Identifiers

SHARE2402

Identifier Type: -

Identifier Source: org_study_id