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

Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin: A Multicenter, Randomized Controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline; Drug: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin

• Study Type: Interventional
• Enrollment (Estimated): 248
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yueyue Li, MD,PhD; Phone Number: 86-18560089751; Email: lyynqj@126.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Contact: Yueyue Li, MD,PhD; Phone Number: 86-18560089751; Email: lyynqj@162.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate	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.	immediately after the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Yueyue Li, MD,PhD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Helicobacter Pylori Infection; Bismuth-containing quadruple therapy
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Antacids; Anti-Infective Agents, Urinary; Levofloxacin; Bismuth; Cefuroxime; Cefuroxime axetil; Tetracycline
• Other Study ID Numbers: SHARE2402

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No