Rescue Therapy for Helicobacter Pylori Infection

• Sponsor: Shanghai Jiao Tong University School of Medicine (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05874544
• Collaborator: (none)
• Enrollment: 513
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 19.5
• Patients Per Site Per Month: 26.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Vonoprazan; Drug: Bismuth Potassium Citrate; Drug: Tetracycline; Drug: Metronidazole; Drug: Amoxicillin; Drug: Rifabutin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 513 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
• Actual Study Start Date: May 16, 2023
• Anticipated Primary Completion Date: Nov 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Helicobacter pylori eradication rate [Six weeks after completion of therapy]

   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).

Secondary Outcome Measures

1. Rate of adverse effects [Within 7 days after completion of therapy]

   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.

2. Compliance rate [Within 7 days after completion of therapy]

   Compliance was defined as poor when they had taken less than 80% of the total medication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

• Shanghai Jiao Tong University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine
• ClinicalTrials.gov Identifier: NCT05874544
• Other Study ID Numbers: rjhy20230001
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hong Lu, MD, Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine, Shanghai Jiao Tong University School of Medicine: Helicobacter pylori; rescue therapy
• Additional relevant MeSH terms: Infections; Helicobacter Infections; Amoxicillin; Metronidazole; Tetracycline; Rifabutin; Potassium Citrate; Bismuth

Study Results

No Results Posted as of May 25, 2023