Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03779087
• Other study ID #: VGHKS18-CT7-22
• Status: Completed
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2023
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

From the profiles of antibiotic susceptibility data following eradication therapy, tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the rescue treatment.

Description:

The H pylori-infected adult patients with failure of standard triple therapy and H pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for 10 days. Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests is performed at six weeks after the end of anti-H pylori therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Consecutive H pylori-infected outpatients, at least 20 years of age with failure of first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth quadruple therapies)

Exclusion Criteria:

• previous allergic reactions to the study medications,
• history of gastrectomy,
• use of antibiotics within the previous 4 weeks,
• pregnant or lactating women,
• coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia, and malignancy).

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• 10d TL quadruple therapy
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.
• 10d AL quadruple therapy
esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Ping-I (William) Hsu, M.D.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Which H. Pylori Was Eradicated	To assess eradication efficacy,repeated endoscopy with rapid urease test, histological	sixth week after the end of anti- H. pylori therapy