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

NCT ID: NCT01742429

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Cure Rate of Helicobacter Pylori Infection

Keywords

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Helicobacter pylori second line treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levofloxacin-bismuth therapy

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

Group Type EXPERIMENTAL

Proton pump inhibitor

Intervention Type DRUG

Bismuth subsalicylate

Intervention Type DRUG

Amoxicillin

Intervention Type DRUG

antibiotic

Levofloxacin

Intervention Type DRUG

antibiotic

classical quadruple therapy

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

Group Type ACTIVE_COMPARATOR

Proton pump inhibitor

Intervention Type DRUG

Bismuth subsalicylate

Intervention Type DRUG

Metronidazole

Intervention Type DRUG

antibiotic

Tetracycline

Intervention Type DRUG

antibiotic

Interventions

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Proton pump inhibitor

Intervention Type DRUG

Bismuth subsalicylate

Intervention Type DRUG

Metronidazole

antibiotic

Intervention Type DRUG

Tetracycline

antibiotic

Intervention Type DRUG

Amoxicillin

antibiotic

Intervention Type DRUG

Levofloxacin

antibiotic

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Hong Lu, MD

Prof. of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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rjkls2012008

Identifier Type: -

Identifier Source: org_study_id