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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.
Sponsor:
Information provided by (Responsible Party):
Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01742429
First received: December 2, 2012
Last updated: August 28, 2014
Last verified: June 2013
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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
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

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: December 2, 2012
Last Updated: August 28, 2014
Health Authority: China: Ethics Committee

Keywords provided by 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
Bismuth
Bismuth subsalicylate
Tetracycline
Amoxicillin
Levofloxacin
Ofloxacin
Metronidazole
Proton Pump Inhibitors
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Antidiarrheals
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on December 02, 2016