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OpenTrials
Completed

NCT Number: NCT01742429

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

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.

Completed

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Key information

Conditions

Cure Rate of Helicobacter Pylori Infection

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proton Pump Inhibitor

Drug

Bismuth Subsalicylate

Drug

Metronidazole

Drug

antibiotic

Tetracycline

Drug

antibiotic

Amoxicillin

Drug

antibiotic

Levofloxacin

Drug

antibiotic

Primary outcomes

  1. eradication rate

    Time frame: 2 months

    urease breath test

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.