Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial

Who is this study for? Patients with Helicobacter Pylori Infection
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Methods: This will be a multi-center, open labeled trial Patients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy Outcome Measurement: Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses. Secondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 90
Healthy Volunteers: f
View:

• Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Mei-Jyh Chen
migichen@ntuh.gov.tw
886-2-23123456
Backup
Yu-Chun Huang
nneder34@gmail.com
Time Frame
Start Date: 2020-07-28
Estimated Completion Date: 2026-12
Participants
Target number of participants: 360
Treatments
Experimental: (B) Empirical therapy
choose antibiotics according to drug history
Active_comparator: (A) Susceptibility testing guided therapy
choose antibiotics according to susceptibility testing
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov