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A Cefuroxime-Containing Treatment Regimen for Penicillin-Allergic Patients with Helicobacter pylori Infection: A Single-Center Prospective Cohort Study

A Cefuroxime-Containing Treatment Regimen for Penicillin-Allergic Patients with Helicobacter pylori Infection: A Single-Center Prospective Cohort Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127085
Enrollment
Unknown
Registered
2026-06-24
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Helicobacter pylori infection

Interventions

Amoxicillin group:None
Cefuroxime group:None

Sponsors

The First Affiliated Hospital, Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years and <= 75 years, regardless of gender; 2. Helicobacter pylori infection confirmed by any of the following methods: 13C/14C urea breath test, gastric biopsy histopathology, or H. pylori culture; 3. No previous H. pylori eradication treatment, or failure of prior eradication treatment with an interval of = 6 months since the last treatment; 4. Voluntary participation in this study and provision of written informed consent; 5. Patients with penicillin allergy (clear history of allergy or positive penicillin skin test) are enrolled in the cefuroxime group, while patients without penicillin allergy are enrolled in the amoxicillin group based on clinical treatment preference.

Exclusion criteria

Exclusion criteria: 1. Use of antibiotics, bismuth, H2-receptor antagonists, proton pump inhibitors (PPIs), tegoprazan, or other acid-suppressing drugs within 4 weeks prior to treatment. 2. Allergy to any drug used in this study (tegoprazan, amoxicillin, cefuroxime, doxycycline, or bismuth). 3. Pregnancy or breastfeeding, or planning to become pregnant during the study period. 4. History of gastrectomy, gastric cancer, recent bleeding (within 4 weeks) from gastroduodenal ulcers, or signs of active bleeding. 5. Severe hepatic or renal dysfunction (ALT/AST > 3 times the upper limit of normal, serum creatinine > 133 µmol/L), cardiovascular disease (such as heart failure, severe arrhythmia), immunodeficiency, malignant tumors, or other severe conditions that may affect study evaluation. 6. Presence of psychiatric disorders, cognitive impairment, or inability to cooperate with follow-up and data collection.

Design outcomes

Primary

MeasureTime frame
Treatment success rate;

Secondary

MeasureTime frame
Incidence of adverse reactions;Medication compliance;

Countries

China

Contacts

Public ContactYan Zhang

The First Affiliated Hospital, Ningbo University

nblc3344@163.com+86 574 87085233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026