Efficacies of Tetracycline-levofloxacin, Standard Bismuth, Amoxicillin-levofloxacin Quadruple Therapy for H.p

Not Applicable

Recruiting

• Conditions: Helicobacter Pylori Eradication
• Interventions: Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole; Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin; Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin

• Registration Number: NCT05850117
• Lead Sponsor: Kaohsiung Medical University

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.

Detailed Description

The "standard tincture quadruple therapy" and the "proton pump inhibitor combined with fluoroquinolone and amoxicillin triple therapy" recommended by the 5th Mazdock-Florence Consensus Conference on the second line of Helicobacter pylori treatment The sterilization rate is not ideal (less than 80%). Recently, we have developed a "Tetracycline combined with levofloxacin quadruple therapy" for first-line treatment failure of H. pylori infection, with a relatively high sterilization rate (\> 95%). A randomized controlled trial confirmed that the elimination rate of "Tetracycline combined with levofloxacin quadruple therapy" was better than "proton pump inhibitor combined with fluoroquinolone" after "standard triple therapy" and "non-tank tetratherapy" sterilization failure. Triple therapy with amoxicillin.

Study Timeline

• Study Start: 2020-02-10
• Status Verified: 2023-04
• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Last Update Submitted: 2023-04-28
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. at least 20 years old
2. subject was failure for the first line therapy of Helicobacter pylori

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Exclusion Criteria

1. Those who are allergic to the drugs used in this study
2. Those who have had a stomach surgery
3. Those who have antibiotics within four weeks of treatment
4. Those who have severe cirrhosis, uremia or malignancy
5. Those who are a pregnant woman or a woman who breastfeeds

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard tincture quadruple therapy	esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole	esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day + tetracycline 500mg four times a day + metronidazole 250mg four times a day
Tetracycline combined with levofloxacin quadruple therapy	esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin	esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ levofloxacin 500mg once a day
amoxicillin combined with levofloxacin quadruple therapy	esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin	esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ amoxicillin 500mg four times a day+ levofloxacin 500mg once a day

Primary Outcome Measures

Name	Time	Method
the rate of Helicobacter pylori	6 week after finish study drugs	evalute eradication outcome by 13C urea breath test

Secondary Outcome Measures

Name	Time	Method
genotype analysis	2 weeks after finishing study drgus	CYP2C19 genotype, IL-1B-511 genotype

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital; 🇨🇳 Kaohsiung, Taiwan