Treatment options for difficult-to-eradicate Helicobacter pylori infections
Rifabutin-containing Triple Therapy for Helicobacter Pylori Rescue Treatment: a Randomized Controlled Trial
PHASE4 · Shanghai Jiao Tong University School of Medicine · NCT05874544
This study is testing different treatment options for people who still have Helicobacter pylori infections after previous treatments to see which one works best.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine (other) |
| Locations | 3 sites (Shanghai, Shanghai and 2 other locations) |
| Trial ID | NCT05874544 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of different treatment regimens for patients with refractory Helicobacter pylori infections. It compares a dual therapy of vonoprazan and amoxicillin against a rifabutin-containing triple therapy and a classical bismuth-containing quadruple therapy. The study aims to determine which of these approaches is most effective in eradicating the infection after previous treatment failures. Participants will be closely monitored for treatment outcomes and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed Helicobacter pylori infection who have previously undergone treatment.
Not a fit: Patients who are naive to H. pylori treatment or have severe systemic diseases or malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more effective treatment options for patients struggling with persistent Helicobacter pylori infections.
How similar studies have performed: Previous studies have shown success with rifabutin-containing therapies for H. pylori, indicating that this approach has potential based on established efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai and 2 other locations
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, Shanghai, China (RECRUITING)
- Shanghai Songjiang District Central Hospital — Shanghai, Shanghai, China (RECRUITING)
- The Second Affiliated Hospital of Zhejiang University school of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Helicobacter Pylori Infection, Helicobacter pylori, rescue therapy