Development of Treatment Algorithm for Eradication of Helicobacter Pylori Based on Antibiotic Susceptibility Test
1 other identifier
interventional
123
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedMay 3, 2016
April 1, 2016
1.9 years
April 26, 2016
April 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
Susceptibility-guided group
ACTIVE COMPARATORDrugs according to antimicrobial susceptibility-guided treatment
triple therapy group
SHAM COMPARATORDrugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
concomitant therapy group
SHAM COMPARATORDrugs - Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
Interventions
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
Eligibility Criteria
You may qualify if:
- \. positive results of rapid urease test
You may not qualify if:
- liver cirrhosis,
- chronic kidney disease,
- bleeding tendency,
- pregnant,
- allergy to antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gangnam Severance Hospital
Seoul, 135720, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 26, 2016
First Posted
May 3, 2016
Study Start
March 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
May 3, 2016
Record last verified: 2016-04