Clinical trial NCT05332444: Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection
Official title: Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection - A Prospective Randomized, Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
antimicrobial susceptibility testing
minimal inhibitory concentration
susceptibility-guided tailored therapy
guideline-recommended empiric therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 450
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This prospective multicenter randomized comparative study will be conducted at the National Taiwan University Hospital, NTUH Bei-Hu Branch, NTUH Hsin-Chu Branch, Taipei City Hospital Renai Branch, Buddhist Tzu Chi General Hospital, and Mennonite Christian Hospital in Hualien. The study protocol will be approved by the independent ethics boards or committees of each hospital. Patients, aged \>= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, these patients will be invited to enter this study for evaluating the efficacy of these rescue regimens.

A computed generated random numbers sequence will be blocked (1:1; block size 6) into two subgroups, say A, and B. After giving written informed consent, each patient will be randomly allocated, to one of two treatment groups:

group A - SG-TT (susceptibility-guided tailored therapy) : treated with 1. clarithromycin triple therapy, or 2. levofloxacin triple therapy, or 3. metronidazole triple therapy, or 4. high-dose dual therapy, or 5. bismuth quadruple therapy, by priority order base on the selection principal through AST with MIC profile;

group B -GR-ET (guidelines-recommended empiric therapy): treated with bismuth quadruple therapy.

All patients will be asked to complete a questionnaire and to record symptoms and drug consumption, and diet content daily during the treatment period. Post-treatment, the patients will be followed up at the Outpatients Clinic to investigate patient adherence and adverse effects of treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by the 13C-urea breath test (UBT). The CYP2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method.

Eligibility criteria: Inclusion Criteria:

Patients, aged \>= 20, having H. pylori-positive chronic gastritis with/without peptic ulcers (duodenal or gastric ulcers) will be recruited. If the patients failed anti-H. pylori therapy previously, they will be invited to enter this study for evaluating the efficacy of these rescue regimens.

Exclusion Criteria:

1. pregnant or nursing woman;
2. serious concomitant illness and malignant tumor of any kind;
3. history of hypersensitivity to test drugs；
4. serious bleeding during the course of this ulcer;
5. previous gastric surgery;
6. receiving bismuth salts, PPIs, or antibiotics in the previous month.

Primary outcomes:
measure: to compare the eradication rate of SG-TT with GR-ET as rescue regimens for H. pylori eradication.
timeFrame: 3.5 years
Secondary outcomes:
measure: to compare the patient adherence and frequency of adverse effects of these treatment regimens
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Chin Yang, M.D.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: