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

Kaohsiung Medical University

Status: Enrolling

Conditions: Helicobacter Pylori Eradication

Treatments: Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin; Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole; Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05850117

KMUHIRB-F(I)-20190136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

Tetracycline combined with levofloxacin quadruple therapy

Active Comparator group

Description:

esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ tetracycline 500mg four times a day+ levofloxacin 500mg once a day

Treatment:

Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin

standard tincture quadruple therapy

Active Comparator group

Description:

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

Treatment:

Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole

amoxicillin combined with levofloxacin quadruple therapy

Active Comparator group

Description:

esomeprazole 40mg twice a day + tripotassium dicitrate bismuthate 300mg four times a day+ amoxicillin 500mg four times a day+ levofloxacin 500mg once a day

Treatment:

Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin