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NCT02759029 Clinical Trial

Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test

Helicobacter Pylori Infection Clinical Trial

Official title:
Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02759029
Other study ID # 3-2015-0193
Secondary ID
Status Recruiting
Phase N/A
First received April 26, 2016
Last updated April 28, 2016
Start date March 2016
Est. completion date February 2018

Study information
Verified date April 2016
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Helicobacter pylori eradication (H. pylori) rates with clarithromycin-based triple therapy are declining, and an alternative strategy is needed urgently. The investigators sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy vs. concomitant therapy for H. pylori eradication in a region with high rates of multiple drug resistance.

Recruitment information / eligibility
Status Recruiting
Enrollment 123
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

1. positive results of rapid urease test

Exclusion Criteria:

1. liver cirrhosis,

2. chronic kidney disease,

3. bleeding tendency,

4. pregnant,

5. allergy to antibiotics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• eradication of Helicobacter pylori
clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk concomitant therapy group Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk bismuth based quadraple therapy Pantoloc 40mg, PO, BID, 1wk Bismuth, 300mg, PO, QID, 1wk Tetracycline, 500mg, PO, QID, 1wk Metronidazole, 500mg, PO, TID, 1wk levofloxacine based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Levofloxacin 500mg, PO, QD, 1wk

Locations
Country Name City State
Korea, Republic of Gangnam Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary eradication rate of Helicobacter pylori the H. pylori status was checked 4 weeks aft er the end of treatment using the 13 C-urea breath test. No
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