NCT04332848 Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection
| NCT ID | NCT04332848 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Taiwan University Hospital |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2020-07-28 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 360 participants in total. It began in 2020-07-28 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aim: Therefore, we aimed to 1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection 2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors. Methods: This will be a multi-center, open labeled trial Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy Outcome Measurement: Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses. Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.
Eligibility Criteria
Inclusion criteria * Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.
Contact & Investigator
Mei-Jyh Chen, MD
PRINCIPAL INVESTIGATOR
National Taiwan University Hospital
Frequently Asked Questions
Who can join the NCT04332848 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 90 Years, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04332848 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04332848 currently recruiting?
Yes, NCT04332848 is actively recruiting participants. Contact the research team at migichen@ntuh.gov.tw for enrollment information.
Where is the NCT04332848 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT04332848 clinical trial?
NCT04332848 is sponsored by National Taiwan University Hospital. The principal investigator is Mei-Jyh Chen, MD at National Taiwan University Hospital. The trial plans to enroll 360 participants.