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

Phase 4

Completed

• Conditions: Cure Rate of Helicobacter Pylori Infection
• Interventions: Drug: Proton pump inhibitor; Drug: Bismuth subsalicylate; Drug: Amoxicillin; Drug: Metronidazole; Drug: Levofloxacin; Drug: Tetracycline

• Registration Number: NCT01742429
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-02
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-06
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin-bismuth therapy	Proton pump inhibitor	14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
Levofloxacin-bismuth therapy	Bismuth subsalicylate	14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
Levofloxacin-bismuth therapy	Amoxicillin	14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
Levofloxacin-bismuth therapy	Levofloxacin	14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin
classical quadruple therapy	Proton pump inhibitor	14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
classical quadruple therapy	Bismuth subsalicylate	14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
classical quadruple therapy	Metronidazole	14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline
classical quadruple therapy	Tetracycline	14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline

Primary Outcome Measures

Name	Time	Method
eradication rate	2 months	urease breath test

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao-Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China