Tailored Juice-guided Eradication Therapy (HP)

Tailored Antibiotic Susceptibility-guided Therapy Via Gastric Juice PCR for First-line H Pylori Eradication, a Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: susceptibility-guided therapy; Drug: empirical clarithromycin-based 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.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: susceptibility-guided therapy; rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of H.pylori eradication	Four-to-six weeks after treatment, all patients received the 13C-urea breath test to confirm H. pylori infection status.	6 weeks

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University
• Investigators: Study Chair: Deng-Chyang Wu, MD, PHD, Kaohsiung Medical University; Principal Investigator: Chao-Hung Kuo, MD, PHD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2016
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: August 18, 2019
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: gastric juice guided therapy; H.pylori eradication
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: KMUHIRB-G(I)-20150043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No