search
Back to results

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

Primary Purpose

Cure Rate of Helicobacter Pylori Infection

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Proton pump inhibitor
Bismuth subsalicylate
Metronidazole
Tetracycline
Amoxicillin
Levofloxacin
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cure Rate of Helicobacter Pylori Infection focused on measuring Helicobacter pylori, second line treatment

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levofloxacin-bismuth therapy

classical quadruple therapy

Arm Description

14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin

14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline

Outcomes

Primary Outcome Measures

eradication rate
urease breath test

Secondary Outcome Measures

Full Information

First Posted
December 2, 2012
Last Updated
August 28, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01742429
Brief Title
Levofloxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cure Rate of Helicobacter Pylori Infection
Keywords
Helicobacter pylori, second line treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin-bismuth therapy
Arm Type
Experimental
Arm Description
14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
Arm Title
classical quadruple therapy
Arm Type
Active Comparator
Arm Description
14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
Intervention Type
Drug
Intervention Name(s)
Proton pump inhibitor
Intervention Type
Drug
Intervention Name(s)
Bismuth subsalicylate
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
antibiotic
Intervention Type
Drug
Intervention Name(s)
Tetracycline
Intervention Description
antibiotic
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
antibiotic
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
antibiotic
Primary Outcome Measure Information:
Title
eradication rate
Description
urease breath test
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Renji Hospital, Shanghai Jiao-Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs