Rescue Therapy for Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874544
• Other study ID #: rjhy20230001
• Status: Recruiting
• Phase: Phase 4
• Start date: May 16, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 357
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Vonoprazan
Proton pump inhibitor
• Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect
• Tetracycline
Antibiotics for H. pylori eradication
• Metronidazole
Antibiotics for H. pylori eradication
• Amoxicillin
Antibiotics for H. pylori eradication
• Rifabutin
Antibiotics for H. pylori eradication

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University school of Medicine	Hangzhou	Zhejiang
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai Songjiang District Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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