Rescue Therapy for Helicobacter Pylori Infection

Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Bismuth Potassium Citrate; Drug: Amoxicillin; Drug: Tetracycline; Drug: Metronidazole; Drug: Vonoprazan; Drug: Rifabutin

• Study Type: Interventional
• Enrollment (Estimated): 513
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Principal Investigator: Hong Lu, M.D.,Ph.D
      • Sub-Investigator: Xiao Liang, M.D.,Ph.D
      • Contact: Yu Huang, M.M.; Phone Number: 86+18621791879; Email: [email protected]
      • Sub-Investigator: Jinnan Chen, M.M.
      • Sub-Investigator: Yixian Guo, M.M.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tetracycline Bismuth Quadruple Therapy; Vonoprazan 20mg bid, Bismuth Potassium Citrate 110mg qid, Tetracycline 500mg qid, Metronidazole 400mg qid	Drug: Bismuth Potassium Citrate; Gastric mucosal protective drug with anti-H. pylori effect; Drug: Tetracycline; Antibiotics for H. pylori eradication; Drug: Metronidazole; Antibiotics for H. pylori eradication; Drug: Vonoprazan; Proton pump inhibitor
Experimental: Rifabutin Triple Therapy; Vonoprazan 20mg bid, amoxicillin 1000mg tid, rifabutin 150mg bid	Drug: Amoxicillin; Antibiotics for H. pylori eradication; Drug: Vonoprazan; Proton pump inhibitor; Drug: Rifabutin; Antibiotics for H. pylori eradication
Experimental: Dual Therapy; Vonoprazan 20mg bid, amoxicillin 1000mg tid	Drug: Amoxicillin; Antibiotics for H. pylori eradication; Drug: Vonoprazan; Proton pump inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).	Six weeks after completion of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance rate	Compliance was defined as poor when they had taken less than 80% of the total medication	Within 7 days after completion of therapy
Rate of adverse effects	The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or severe" (causing considerable interference with daily activities). In addition, blood test were messured to access function of liver and kidney.	Within 7 days after completion of therapy

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Helicobacter pylori; rescue therapy
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Protein Synthesis Inhibitors; Respiratory System Agents; Antiprotozoal Agents; Antiparasitic Agents; Antitubercular Agents; Antibiotics, Antitubercular; Expectorants; Antacids; Metronidazole; Rifabutin; Amoxicillin; Bismuth; Tetracycline; Potassium Citrate
• Other Study ID Numbers: rjhy20230001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No