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

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ClinicalTrials.gov Identifier: NCT01742429
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : August 29, 2014
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine

Brief 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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levofloxacin-bismuth therapy
14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
Drug: Proton pump inhibitor
Drug: Bismuth subsalicylate
Drug: Amoxicillin
antibiotic

Drug: Levofloxacin
antibiotic

Active Comparator: classical quadruple therapy
14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
Drug: Proton pump inhibitor
Drug: Bismuth subsalicylate
Drug: Metronidazole
antibiotic

Drug: Tetracycline
antibiotic




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



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742429


Locations
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

Responsible Party: Hong Lu, MD, Prof. of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01742429     History of Changes
Other Study ID Numbers: rjkls2012008
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: June 2013

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

Additional relevant MeSH terms:
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Levofloxacin
Ofloxacin
Tetracycline
Metronidazole
Proton Pump Inhibitors
Bismuth
Bismuth subsalicylate
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents, Urinary
Renal 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
Antacids
Gastrointestinal Agents
Protein Synthesis Inhibitors
Antidiarrheals