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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Cure Rate of Helicobacter Pylori Infection

Treatments: Drug: Amoxicillin; Drug: Levofloxacin; Drug: Proton pump inhibitor; Drug: Metronidazole; Drug: Tetracycline; Drug: Bismuth subsalicylate

Study type: Interventional

Funder types: Other

Identifiers

NCT01742429

rjkls2012008

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Levofloxacin-bismuth therapy

Experimental group

Description:

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

Treatment:

Drug: Bismuth subsalicylate

Drug: Levofloxacin

Drug: Amoxicillin

Drug: Proton pump inhibitor

classical quadruple therapy

Active Comparator group

Description:

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

Treatment:

Drug: Bismuth subsalicylate

Drug: Tetracycline

Drug: Proton pump inhibitor

Drug: Metronidazole