MedTrace Logo

Comparison of the Levofloxacin Sequential Therapy and Quadruple Therapy in Second Line Treatment for HP

NCT03148366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2022-06-08

No results posted yet for this study

Summary

Objectives: Eradication of H. pylori infection could reduce the occurence or recurrence of gastric cancer and peptic ulcer diseases. However, it was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy. Bismuth quadruple therapy and triple therapy containing levofloxacin are currently the recommended rescue therapies in the second line and third line treatment. Recently, our pilot study showed that modified sequential therapy containing levofloxacin achieved high eradication rate (95%) in the second line therapy. The regimen includes a PPI plus amoxicillin for 5-7 days, followed by a PPI plus levofloxacin and metronidazole for another 5-7 days. However, whether this modified sequential therapy containing levofloxacin is more effective than bismuth quadruple therapy in the second line and third line treatment remains unknown. Besides, the impact of these regimens on the antibiotic resistance , microbiota of gut flora, and metabolic factors remains unknown.

Aims: Therefore, the investigators aimed to

1. compare the eradication rates and long term re-infection rates of sequential therapy containing levofloxacin for 14 days versus bismuth quadruple therapy for 10 days in the second line and third line treatment
2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
3. assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
4. assess the impact of eradication therapy on the metabolic factors

Conditions

  • Helicobacter

Interventions

DRUG

Levofloxacin based sequential therapy

D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days

DRUG

bismuth quadruple therapy for 10 days (BQ)

D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Ming-Shiang Wu · National Taiwan University Hospital

  • Jyh-Ming Liou · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03148366 on ClinicalTrials.gov