Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital

About this trial

The prevalence of H. pylori antibiotic resistance has reached an alarming level worldwide. Antibiotic stewardship programs should be urgently developed and implemented. However, H. pylori antimicrobial susceptibility testing (AST) is rarely offered, making local resistance patterns not easily available. Guideline-recommended empiric therapies (GR-ET) may no longer reliably achieve high cure rate in the era of increasing antibiotic resistance. susceptibility-guided tailored therapy (SG-TT) may be a good choice to solve this problem.

The aims of this study are:

1. to compare the efficacy of SG-TT with GR-ET as rescue regimens for H. pylori eradication; 2. to compare the patient adherence and adverse effects of these treatment regimens; 3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

pregnant or nursing woman;

serious concomitant illness and malignant tumor of any kind;

history of hypersensitivity to test drugs;

serious bleeding during the course of this ulcer;

Trial design

Design model

Parallel

Treatments tested in this trial

  • susceptibility-guided tailored therapy (Group A)

    Drug

    Includes 5 treatment options. The priority order of treatment regimens is based on the selection principal through AST with MIC profile. 1\. clarithromycin triple therapy: include rabeprazole 20mg bid, amoxicillin 1 g bid, and clarithromycin 500 mg bid, for 14 days; or 2. levofloxacin triple therapy: include rapeprazole 20 mg bid, amoxicillin 1 g bid, and levofloxacin 500 mg bid, for 14 days; or 3. metronidazole triple therapy: include rabeprazole 20 mg bid, amoxicillin 500 mg qid, and metronidazole 250 mg qid, for 14 days; or 4. high-dose dual therapy: include rabeprazole 20 mg qid, amoxicillin 750 mg qid, for 14 days; or 5. bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.

  • guidelines-recommended empiric therapy (Group B)

    Drug

    bismuth quadruple therapy: include rabeprazole 20 mg bid, bismuth 120 mg qid, metronidazole 500 mg tid, and tetracycline 500 mg qid, for 14 days.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: susceptibility-guided tailored therapy (Group A)Experimental treatment 1 intervention
Group B: guidelines-recommended empiric therapy (Group B)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

to compare the eradication rate of SG-TT with GR-ET as rescue regimens for H. pylori eradication.

The eradication rate (efficacy) of these regimens will be evaluated by the result of C13-UBT in intention-to treat (ITT) and per-protocol (PP) analysis.

Time frame
3.5 years

Secondary outcomes

1

to compare the patient adherence and frequency of adverse effects of these treatment regimens

The frequency of adverse events will be evaluated by the number of participant with adverse events and patient adherence will be evaluated by counting unused medication after the treatment.

Time frame
3.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.