Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p
1 other identifier
interventional
240
1 country
1
Brief Summary
- 1.Compare the efficacy of "Tetracycline combined with levofloxacin quadruple therapy", "standard tincture quadruple therapy" and "amoxicillin combined with levofloxacin quadruple therapy" on the second line of Helicobacter pylori sterilization.
- 2.To investigate the drug resistance of Helicobacter pylori and the host genotypes of CYP2C19 and IL-1B-511 on the sterilizing effect of three second-line Helicobacter pylori.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2020
CompletedFirst Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 9, 2023
April 1, 2023
4.9 years
April 28, 2023
April 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
the rate of Helicobacter pylori
evalute eradication outcome by 13C urea breath test
6 week after finish study drugs
Secondary Outcomes (1)
genotype analysis
2 weeks after finishing study drgus
Study Arms (3)
Tetracycline combined with levofloxacin quadruple therapy
ACTIVE COMPARATOResomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ levofloxacin 500mg once a day
standard tincture quadruple therapy
ACTIVE COMPARATOResomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day \+ tetracycline 500mg four times a day + metronidazole 250mg four times a day
amoxicillin combined with levofloxacin quadruple therapy
ACTIVE COMPARATOResomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ amoxicillin 500mg four times a day+ levofloxacin 500mg once a day
Interventions
Tetracycline combined with levofloxacin quadruple therapy
standard tincture quadruple therapy
amoxicillin combined with levofloxacin quadruple therapy
Eligibility Criteria
You may qualify if:
- at least 20 years old
- subject was failure for the first line therapy of Helicobacter pylori
You may not qualify if:
- Those who are allergic to the drugs used in this study
- Those who have had a stomach surgery
- Those who have antibiotics within four weeks of treatment
- Those who have severe cirrhosis, uremia or malignancy
- Those who are a pregnant woman or a woman who breastfeeds
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kaohsiung Medical University Hospital
Kaohsiung City, 807, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- clinical professor
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 9, 2023
Study Start
February 10, 2020
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
May 9, 2023
Record last verified: 2023-04