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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06351891

Enrollment

248

Registered

2024-04-08

Start date

2024-04-30

Completion date

2024-12-31

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori Infection, Bismuth-containing quadruple therapy

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.

Interventions

DRUG14-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.

DRUG14-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactYueyue Li, MD,PhD

lyynqj@126.com86-18560089751

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026