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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351891
• Other study ID #: SHARE2402
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Qilu Hospital of Shandong University
• Contact: Yueyue Li, MD,PhD
• Phone: 86-18560089751
• Email: lyynqj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 248
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of adverse reactions	Rate of adverse reactions	immediately after the procedure
Secondary	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