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

NCT03779087 | Completed DMC

• 1 other identifier: VGHKS18-CT7-22
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Eradication rate; Rescue treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

10d TL quadruple therapy

EXPERIMENTAL

esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days

Drug: 10d TL quadruple therapy

10d AL quadruple therapy

ACTIVE COMPARATOR

esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days

Drug: 10d AL quadruple therapy

Interventions

10d TL quadruple therapy DRUG

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.

Also known as: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, tetracycline 500 mg, levofloxacin 500 mg

10d TL quadruple therapy

10d AL quadruple therapy DRUG

esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.

Also known as: esomeprazole 40 mg, tripotassium dicitrate bismuthate 300mg, amoxicillin 500 mg, levofloxacin 500 mg

10d AL quadruple therapy

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ping-I (William) Hsu, M.D.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Interventions

Esomeprazole; Tetracycline; Levofloxacin; Amoxicillin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Ping-I Hsu, Bachelor

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: December 19, 2018
• Study Start: July 11, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

TW (1)