Antibiotic Resistant Infection, Helicobacter Pylori Infection
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTDual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results
Sponsors
Incheon St.Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Empirical treatment versus tailored therapy
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication success | 8-12 weeks after eradication | H. pylori eradication success based on urea breath test |
Countries
South Korea
Outcome results
None listed