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Vonoprazan and tetracycline dual therapy as first-line treatment for Helicobacter pylori infection in patients allergic to penicillin: A prospective, multicenter,randomized controlled, open label trial

Vonoprazan and tetracycline dual therapy as first-line treatment for Helicobacter pylori infection in patients allergic to penicillin: A prospective, multicenter,randomized controlled, open label trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085879
Enrollment
Unknown
Registered
2024-06-20
Start date
2024-08-05
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Helicobacter pylori infection

Interventions

Experimental group 1:high-dose Vonoprazan-tetracycline dual
Experimental group 2:low-dose Vonoprazan-tetracycline dual

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1: participants aged 18–70 2: no history of of receiving H. pylori eradication therapy 3: confirmed H. pylori infection by at least one of the following tests: urea breath test, histology exam and positive bacterial culture 4: history of allergic to penicillin or positive in penicillin allergy skin test

Exclusion criteria

Exclusion criteria: 1: used antibiotics,bismuth,or acid inhibitor use, including H2 receptor antagonist, PPI or P-CAB within four weeks before inclusion 2: current pregnancy or breastfeeding 3: allergy to any of the study drugs 4: history of gastrectomy 5: gastric malignancy 6: Gastroduodenal ulcer with recent hemorrhage or signs of hemorrhage within 4 weeks 7: preexisting serious diseases or clinical conditions that might interfere with the evaluation of study treatment, including patients with active central nervous system disorders and hematological disorders, hepatic or renal dysfunction, heart disorders, etc. 8: difficulty with oral feeding or receiving parenteral nutrition support 9: administration of ampicillin, amoxicillin, estradiol, diethylstilbestrol, glibenclamide, glipizide, glimepiride, potassium citrate, progesterone, toluenesulfonylurea, magnesium sulfate, magnesium aluminum carbonate, aluminum hydroxide, calcium lactate, atazanavir, nelfinavir, or rilpivirine, erlotinib, gefitinib, pembrolizumab, ceritinib, or soridjib, midazolam, digoxin, voriconazole, clopidogrel, isotretinoin, avicularin, retinol, bexarotene, barbiturates, sodium phenytoin, carbamazepine, anticoagulants, mezlibenzone, tegafur, methotrexate, or rifampin during the trial

Design outcomes

Primary

MeasureTime frame
Eradication rates of Helicobacter pylori;

Secondary

MeasureTime frame
adverse events;compliance;

Countries

China

Contacts

Public ContactTianlian Yan

The First Affiliated Hospital, Zhejiang University School of Medicine

583195088@qq.com+86 134 8638 8649

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026