Tailored Juice-guided Eradication Therapy

NCT ID: NCT04061447

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-05
• Study Completion Date: 2019-07-31

Brief Summary

In this study, the investigators aim to investigate the efficacy of tailored anti-microbial susceptibility guided-therapy via gastric juice PCR, compared with empirical standard triple therapy.

Detailed Description

The eradication of H. pylori is an important clinical issue due to its association with many gastrointestinal diseases such as peptic ulcer and even gastric cancer. However, with the global trend of increasing antibiotic resistance, the eradication rate of clarithromycin-based standard triple therapy has declined to less than 80%. To overcome such alarming antibiotic resistance, antimicrobial susceptibility-guided therapy is recommended. However, the literature on gastric juice PCR as susceptibility-guided therapy is scant; therefore, the investigators conducted this prospective randomized controlled trial with the aim of investigating the efficacy of antibiotic susceptibility-guided therapy via gastric juice PCR for first-line eradication.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

susceptibility-guided therapy

In the group of the empirical triple therapy, patients received rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.

Group Type: EXPERIMENTAL

susceptibility-guided therapy

Intervention Type: DRUG

rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.

empirical clarithromycin-based triple therapy

In the group of gastric juice susceptibility-guided therapy, the eradication regimen was based on the susceptibility results of gastric PCR. If clarithromycin was sensitive, the regimen contained rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days. If clarithromycin was resistant and levofloxacin was sensitive, the regimen was rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and levofloxacin 500mg QD for seven days. If clarithromycin and levofloxacin were both resistant, the regimen was either reverse-hybrid therapy (rabeprazole 20mg B.I.D x 14 days, amoxicillin 1000mg B.I.D, x 14 days, clarithromycin 500mg B.I.D for 7 days, and metronidazole 500mg B.I.D for 7 days) or high dose dual therapy (rabeprazole 20mg Q.I.D and amoxicillin 1000mg Q.I.D for 14 days). Owing to this open design, either reverse-hybrid therapy or high dose dual therapy was chosen by doctors' preference.

Group Type: ACTIVE_COMPARATOR

empirical clarithromycin-based triple therapy

Intervention Type: DRUG

The eradication regimen was based on the susceptibility results of gastric PCR. If clarithromycin was sensitive, the regimen contained rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days. If clarithromycin was resistant and levofloxacin was sensitive, the regimen was rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and levofloxacin 500mg QD for seven days. If clarithromycin and levofloxacin were both resistant, the regimen was either reverse-hybrid therapy (rabeprazole 20mg B.I.D x 14 days, amoxicillin 1000mg B.I.D, x 14 days, clarithromycin 500mg B.I.D for 7 days, and metronidazole 500mg B.I.D for 7 days) or high dose dual therapy (rabeprazole 20mg Q.I.D and amoxicillin 1000mg Q.I.D for 14 days). Owing to this open design, either reverse-hybrid therapy or high dose dual therapy was chosen by doctors' preference.

Interventions

susceptibility-guided therapy

rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.

Intervention Type: DRUG

empirical clarithromycin-based triple therapy

The eradication regimen was based on the susceptibility results of gastric PCR. If clarithromycin was sensitive, the regimen contained rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days. If clarithromycin was resistant and levofloxacin was sensitive, the regimen was rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and levofloxacin 500mg QD for seven days. If clarithromycin and levofloxacin were both resistant, the regimen was either reverse-hybrid therapy (rabeprazole 20mg B.I.D x 14 days, amoxicillin 1000mg B.I.D, x 14 days, clarithromycin 500mg B.I.D for 7 days, and metronidazole 500mg B.I.D for 7 days) or high dose dual therapy (rabeprazole 20mg Q.I.D and amoxicillin 1000mg Q.I.D for 14 days). Owing to this open design, either reverse-hybrid therapy or high dose dual therapy was chosen by doctors' preference.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. male or non-pregnant female aged more than 20 yeasrs

2. H.pylori infection

3. Mental and legal ability to give a written infomed consent

Exclusion Criteria

1. pregnant women

2. previous allergic reaction to antibiotics (clarithromycin, amoxicillin, levofloxacin, metronidazole and Proton-pump inhibitor(rabeprazole)

3. patients with previous gastric surgery

4. the coexistence of serious concomitant illness(for example, decompensated liver cirrhosis, uremia)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University

OTHER

Sponsor Role: lead

Responsible Party

DENG-CHYANG WU

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deng-Chyang Wu, MD, PHD

Role: STUDY_CHAIR

Kaohsiung Medical University

Chao-Hung Kuo, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

Other Identifiers

KMUHIRB-G(I)-20150043

Identifier Type: -

Identifier Source: org_study_id