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

This study has been completed.
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine Identifier:
First received: December 2, 2012
Last updated: August 28, 2014
Last verified: June 2013
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.

Condition Intervention Phase
Cure Rate of Helicobacter Pylori Infection
Drug: Proton pump inhibitor
Drug: Bismuth subsalicylate
Drug: Metronidazole
Drug: Tetracycline
Drug: Amoxicillin
Drug: Levofloxacin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • eradication rate [ Time Frame: 2 months ]
    urease breath test

Enrollment: 200
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.
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Please refer to this study by its identifier: NCT01742429

China, Shanghai
Renji Hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

Responsible Party: Hong Lu, MD, Prof. of Medicine, Shanghai Jiao Tong University School of Medicine Identifier: NCT01742429     History of Changes
Other Study ID Numbers: rjkls2012008
Study First Received: December 2, 2012
Last Updated: August 28, 2014

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Helicobacter pylori
second line treatment

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bismuth subsalicylate
Proton Pump Inhibitors
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Gastrointestinal Agents
Protein Synthesis Inhibitors processed this record on May 24, 2017