Optimal Tailored Treatment for H. Pylori Infection

Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance

The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection; Antibiotic Resistant Infection
• Intervention / Treatment: Diagnostic test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)

Detailed Description

Patients are randomly assigned to the empirical therapy group and tailored therapy group.

The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.

Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.

• Study Type: Interventional
• Enrollment (Anticipated): 1988
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Byung-Wook Kim, MD, PhD; Phone Number: 82-32-280-5057; Email: gastro@catholic.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection

Exclusion Criteria:

• subjects younger than 18 years old
• subjects with a history of H pylori eradication
• subjects who had previous gastric surgery
• subjects who were pregnant or lactating
• subjects with serious concurrent illness
• subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study
• subjects with a history of allergy to any one of the compounds in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Empirical therapy for H. pylori infection; The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication	Diagnostic test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR); Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results
EXPERIMENTAL: Tailored therapy for H. pylori infection; The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR.	Diagnostic test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR); Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication success	H. pylori eradication success based on urea breath test	8-12 weeks after eradication

Collaborators and Investigators

• Sponsor: Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): March 31, 2024
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: July 4, 2020
• First Posted (ACTUAL): July 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 4, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: XC20ENDT0022

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