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

Phase 4

Not yet recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline; Drug: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

• Registration Number: NCT06351891
• Lead Sponsor: Qilu Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-04
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Study First Posted: 2024-04-08
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 248

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
14-day bismuth quadruple regimen containing cefuroxime and tetracycline	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.
14-day bismuth quadruple regimen containing cefuroxime and levofloxacin	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.

Primary Outcome Measures

Name	Time	Method
Eradication rate	immediately after the procedure	Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups.

Secondary Outcome Measures

Name	Time	Method
Rate of adverse reactions	immediately after the procedure	Rate of adverse reactions
Patient compliance	immediately after the procedure	Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China