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

Helicobacter Pylori Eradication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05850117
• Other study ID #: KMUHIRB-F(I)-20190136
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Kaohsiung Medical University
• Contact: Deng-Chyang Wu, MD, PhD
• Phone: 88673121101
• Email: dechwu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Eradication

Intervention

Drug:
• esomeprazole, tripotassium dicitrate bismuthate, tetracycline and levofloxacin
Tetracycline combined with levofloxacin quadruple therapy
• esomeprazole , tripotassium dicitrate bismuthate, tetracycline 500mg and metronidazole
standard tincture quadruple therapy
• esomeprazole, tripotassium dicitrate bismuthate , amoxicillin and levofloxacin
amoxicillin combined with levofloxacin quadruple therapy

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of Helicobacter pylori	evalute eradication outcome by 13C urea breath test	6 week after finish study drugs
Secondary	genotype analysis	CYP2C19 genotype, IL-1B-511 genotype	2 weeks after finishing study drgus