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CompletedNCT01742429Updated Aug 29, 2014

Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

A Phase 4 interventional study of Proton pump inhibitor and Bismuth subsalicylate in Cure Rate of Helicobacter Pylori Infection, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-29.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.

02

Conditions studied

  • Cure Rate of Helicobacter Pylori Infection

Keywords

  • Helicobacter pylori
  • second line treatment
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 200 is above the median of 120 across 4,200 interventional studies indexed under Infections.

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Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.

Exclusion criteria

Exclusion Criteria:

  • patients less than 18 years old,
  • previous gastric surgery,
  • pregnancy,
  • lactation,
  • major systemic diseases,
  • administration of antibiotics,
  • bismuth,
  • antisecretory drugs in the preceding 8 weeks, or
  • allergy to any one of the medication used in the quadruple regimens.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Levofloxacin-bismuth therapy

    14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin

    Drug: Proton pump inhibitor · Drug: Bismuth subsalicylate · Drug: Amoxicillin · Drug: Levofloxacin

  • Active comparator
    classical quadruple therapy

    14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline

    Drug: Proton pump inhibitor · Drug: Bismuth subsalicylate · Drug: Metronidazole · Drug: Tetracycline

Interventions

  • DrugProton pump inhibitor
  • DrugBismuth subsalicylate
  • DrugMetronidazole

    antibiotic

  • DrugTetracycline

    antibiotic

  • DrugAmoxicillin

    antibiotic

  • DrugLevofloxacin

    antibiotic

06

What researchers measure

Primary outcomes

  1. eradication rate

    urease breath test

    Time frame: 2 months

07

Study locations

1 site
  • Renji Hospital, Shanghai Jiao-Tong University School of Medicine
    Shanghai, Shanghai 200127, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01742429
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Hong Lu, MD (Prof. of Medicine, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Dec 5, 2012
Start date
Nov 2012
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Aug 29, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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