NCT04462133

Optimal Tailored Treatment for H. Pylori Infection

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Incheon St.Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 79 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Helicobacter Pylori Infection
• Antibiotic Resistant Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-03-31
• Completion: 2024-10-01
• First posted: 2020-07-08
• Last updated: 2024-05-16

Locations

1 site across 1 country: South Korea