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Efficacy and Safety of 7-day Triple Therapy Containing Amoxicillin and Tetracycline Versus 14-day Dual Therapy for Helicobacter Pylori Eradication

Efficacy and Safety of 7-day Triple Therapy Containing Amoxicillin and Tetracycline Versus 14-day Dual Therapy for Helicobacter Pylori Eradication

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07333001
Acronym
PSM
Enrollment
508
Registered
2026-01-12
Start date
2025-11-01
Completion date
2025-12-27
Last updated
2026-01-12

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

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori, triple therapy, dual therapy

Brief summary

With the increasing prevalence of antibiotic resistance, the clinical efficacy of conventional 7-day triple therapy for Helicobacter pylori eradication has been substantially diminished. However, the efficacy and safety of a 7-day triple regimen based on amoxicillin and tetracycline warrant further investigation. This retrospective study was designed to compare the efficacy and safety of a 7-day triple therapy based on amoxicillin and tetracycline combination versus the standard 14-day high-dose dual therapy for H. pylori infection. Data on therapies for H. pylori eradication were extracted between January 2023 and October 2025 at Qilu Hospital of Shandong University. Two regimens were compared based on 1:3 propensity score matching: 7-day triple therapy (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily) and 14-day high-dose dual therapy (vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily). Eradication rates and incidence of adverse events were assessed.

Interventions

DRUG7-day triple therapy

vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and tetracycline 500 mg four times daily for 7 days

DRUG14-day dual therapy

vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days

Sponsors

Qilu Hospital of Shandong University
CollaboratorOTHER
Yueyue Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* patients aged 18-70 years; * patients with H. pylori infection confirmed by 13C/14C-urea breath test or rapid urease test; * patients with no history of H. pylori eradication therapy

Exclusion criteria

* patients with severe underlying diseases, such as hepatic insufficiency, renal insufficiency, immunosuppression, malignant tumors, and coronary heart disease; * patients with active gastrointestinal bleeding; * patients with a history of upper gastrointestinal surgery; * patients allergic to treatment drugs; * patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks; * patients who were pregnant or lactating or unwilling to take contraceptive measures during the trial; * patients with other behaviors that may increase the risk of disease, such as alcohol and drug abuse; * incomplete data.

Design outcomes

Primary

MeasureTime frame
eradication ratesix weeks after treatment

Secondary

MeasureTime frame
incidence of adverse eventsimmediately after treatment

Countries

China

Outcome results

None listed

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