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

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.

Study Overview

• Status: Completed
• Conditions: Cure Rate of Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Bismuth subsalicylate; Drug: Amoxicillin; Drug: Proton pump inhibitor; Drug: Levofloxacin; Drug: Metronidazole; Drug: Tetracycline

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Levofloxacin-bismuth therapy; 14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin	Drug: Bismuth subsalicylate; Drug: Amoxicillin; antibiotic; Drug: Proton pump inhibitor; Drug: Levofloxacin; antibiotic
Active Comparator: classical quadruple therapy; 14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline	Drug: Bismuth subsalicylate; Drug: Proton pump inhibitor; Drug: Metronidazole; antibiotic; Drug: Tetracycline; antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eradication rate	urease breath test	2 months

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 2, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): August 29, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Helicobacter pylori; second line treatment
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Cytochrome P-450 CYP1A2 Inhibitors; Antacids; Anti-Infective Agents, Urinary; Renal Agents; Antidiarrheals; Metronidazole; Amoxicillin; Levofloxacin; Ofloxacin; Bismuth; Bismuth subsalicylate; Tetracycline; Proton Pump Inhibitors
• Other Study ID Numbers: rjkls2012008