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

Cure Rate of Helicobacter Pylori Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742429
• Other study ID #: rjkls2012008
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2012
• Last updated: August 28, 2014
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cure Rate of Helicobacter Pylori Infection
• Helicobacter Infections

Intervention

Drug:
• Proton pump inhibitor

• Bismuth subsalicylate

• Metronidazole
antibiotic
• Tetracycline
antibiotic
• Amoxicillin
antibiotic
• Levofloxacin
antibiotic

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao-Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eradication rate	urease breath test	2 months	Yes