N/A
N=219
The Efficacy of the Tailored Therapy Based on Antimicrobial Susceptibility for 2nd Eradication of H. Pylori
Helicobacter Infection
Bottom Line
View on ClinicalTrials.gov: NCT02349685 ↗Enrolled (actual)
219
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Number of Participants in Each Arm/Group With Successful H. Pylori Eradication — 67; 63; 36 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- H. pylori culture and antimicrobial susceptibility test (Procedure); 14 day PBMT group (Drug); 14 day MEA group (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seoul National University Bundang Hospital
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Each Arm/Group With Successful H. Pylori Eradication |
67; 63; 37 | — |
| SECONDARY Number of Participants in Each Arm/Group With Successful H. Pylori Eradication |
67; 63; 37 | — |
Summary
As increasing the antibiotics resistance, the effectiveness of traditional Helicobacter pylori (H. pylori) therapies has been declined coincidently. In this study, the investigators evaluated the efficacy of H. pylori eradication between a personalized therapy for H. pylori infection based on the results of antibiotics resistance by using H. pylori culture and minimal inhibitory concentration (MIC) and the traditional 2nd rescue regimens, and the investigators analyzed the prevalence of the antibiotic resistance after 1st eradication of H. pylori in the tailored therapy group.
Eligibility Criteria
Inclusion Criteria
- The patients who proved a failure of 1st eradication of H. pylori with Proton pump inhibitor based triple therapy (PPI bid + amoxacillin 1g b.i.d + Clarithromycin 500 mg b.i.d) or sequential therapy (initial 5-day therapy with a combination of PPI b.i.d and amoxicillin 1g b.i.d, followed by 5 days of PPI b.i.d., clarithromycin 500mg b.i.d., and metronidazole 500mg t.i.d) following three methods
- positive rapid urease test (CLOtest)
- histologic evidence of H. pylori by modified Giemsa staining
- positive 13C-Urea breath test
- Male and female Korean Adult (Aged ≥ 18 years)
Exclusion Criteria
- Patients who received two or more eradication therapy for H. pylori infection
- H. pylori eradication failure because of poor compliance
- the administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
- Advanced gastric cancer or other malignancy
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
- Other severe concurrent diseases
- Previous allergic reactions to the study drugs
- Pregnant or lactating women
Data sourced from ClinicalTrials.gov (NCT02349685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.