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

Efficacies of Tetracycline-levofloxacin Quadruple Therapy, Standard Bismuth Quadruple Therapy and Amoxicillin-levofloxacin Quadruple Therapy in the Second-line Treatment of H Pylori Infection

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Eradication
• Intervention / Treatment: Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin; Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole; Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deng-Chyang Wu, MD, PHD; Phone Number: 7451 88673121101; Email: dechwu@yahoo.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Recruiting
    • Kaohsiung Medical University Hospital
    • Contact: Deng-Chyang Wu, MD,PHD; Phone Number: 7451 886-7-3121101; Email: dechwu@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin; Tetracycline combined with levofloxacin quadruple therapy
Active Comparator: 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	Drug: esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole; standard tincture quadruple therapy
Active Comparator: 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	Drug: esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin; amoxicillin combined with levofloxacin quadruple therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the rate of Helicobacter pylori	evalute eradication outcome by 13C urea breath test	6 week after finish study drugs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
genotype analysis	CYP2C19 genotype, IL-1B-511 genotype	2 weeks after finishing study drgus

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Metronidazole; Amoxicillin; Levofloxacin; Ofloxacin; Esomeprazole; Tetracycline
• Other Study ID Numbers: KMUHIRB-F(I)-20190136

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No