Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

Yanqing Li

Status: Not yet enrolling

Conditions: HELICOBACTER PYLORI INFECTIONS

Treatments: Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy; Drug: 14-day vonoprazan-amoxicillin dual therapy; Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07179159

202509

Details and patient eligibility

About

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

Enrollment: 372 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-70 years, male or female
2. Current Helicobacter pylori infection (positive 13C-urea breath test)
3. No prior Helicobacter pylori eradication therapy

Exclusion criteria

1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
2. Active gastrointestinal bleeding
3. History of upper gastrointestinal surgery
4. History of drug hypersensitivity
5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
6. Pregnant or lactating women
7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
8. Individuals unable or unwilling to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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372 participants in 3 patient groups

14-day vonoprazan-amoxicillin dual therapy

Experimental group

Treatment:

Drug: 14-day vonoprazan-amoxicillin dual therapy

14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

Active Comparator group

Treatment:

Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy

14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

Active Comparator group

Treatment:

Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy