Rescue Therapy for Helicobacter Pylori Infection

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Tetracycline; Drug: Metronidazole; Drug: Amoxicillin; Drug: Bismuth Potassium Citrate; Drug: Vonoprazan; Drug: Rifabutin

Study type: Interventional

Funder types: Other

Identifiers

NCT05874544

rjhy20230001

Details and patient eligibility

About

Dual therapy containing vonoprazan and amoxicillin had showed excellent eradication results with Helicobacter pylori first-line treatment. However, no study has examined its efficacy for H. pylori rescue treatment. Rifabutin has low antibiotic resistance, superior antibacterial activity in vitro, and stability in the gastric acid environment. Several studies have confirmed the efficacy of rifabutin-containing triple therapy as a first-line or rescue treatment for H. pylori. The purpose of this study was to evaluate the efficacy and safety of dual therapy vesus rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori.

Enrollment: 360 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with previous treatment experience

Exclusion criteria

• subjects naive to H. pylori treatment,
• under 18 or over 80 years old
• history of gastrectomy
• pregnant or lactating women
• Previous history of tuberculosis
• Allergy to any of the study drugs
• severe systemic diseases or malignancy
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups

Tetracycline Bismuth Quadruple Therapy

Active Comparator group

Description:

Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid

Treatment:

Drug: Bismuth Potassium Citrate

Drug: Vonoprazan

Drug: Metronidazole

Drug: Tetracycline

Rifabutin Triple Therapy

Experimental group

Description:

Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid

Treatment:

Drug: Rifabutin

Drug: Vonoprazan

Drug: Amoxicillin

Dual Therapy

Experimental group

Description:

Vonoprazan 20mg bid, amoxicillin 1000mg tid

Treatment:

Drug: Vonoprazan

Drug: Amoxicillin