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):
Dr. HONG LU, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01742429
First received: December 2, 2012
Last updated: June 1, 2013
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
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
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

No publications provided

Responsible Party: Dr. HONG LU, 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: June 1, 2013
Health Authority: China: Ethics Committee

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
Tetracycline
Amoxicillin
Ofloxacin
Metronidazole
Bismuth
Bismuth subsalicylate
Proton Pump Inhibitors
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antacids
Antidiarrheals
Gastrointestinal Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 16, 2014