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

NCT ID: NCT05850117

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Helicobacter Pylori Eradication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1.Tetracycline combined with levofloxacin quadruple therapy 2. standard tincture quadruple therapy 2. amoxicillin combined with levofloxacin quadruple therapy
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tetracycline combined with levofloxacin quadruple therapy

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

Group Type ACTIVE_COMPARATOR

esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin

Intervention Type DRUG

Tetracycline combined with levofloxacin quadruple therapy

standard tincture quadruple therapy

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

Group Type ACTIVE_COMPARATOR

esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole

Intervention Type DRUG

standard tincture quadruple therapy

amoxicillin combined with levofloxacin quadruple therapy

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

Group Type ACTIVE_COMPARATOR

esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin

Intervention Type DRUG

amoxicillin combined with levofloxacin quadruple therapy

Interventions

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esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin

Tetracycline combined with levofloxacin quadruple therapy

Intervention Type DRUG

esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole

standard tincture quadruple therapy

Intervention Type DRUG

esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin

amoxicillin combined with levofloxacin quadruple therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University

OTHER

Sponsor Role lead

Responsible Party

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DENG-CHYANG WU

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Deng-Chyang Wu, MD, PhD

Role: CONTACT

88673121101 ext. 7451

Facility Contacts

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Deng-Chyang Wu, MD,PHD

Role: primary

886-7-3121101 ext. 7451

Other Identifiers

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KMUHIRB-F(I)-20190136

Identifier Type: -

Identifier Source: org_study_id

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