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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01742429
Enrollment
200
Registered
2012-12-05
Start date
2012-11-30
Completion date
2013-04-30
Last updated
2014-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cure Rate of Helicobacter Pylori Infection

Keywords

Helicobacter pylori, second line treatment

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.

Interventions

DRUGProton pump inhibitor
DRUGBismuth subsalicylate
DRUGMetronidazole

antibiotic

DRUGTetracycline

antibiotic

DRUGAmoxicillin

antibiotic

DRUGLevofloxacin

antibiotic

Sponsors

Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
eradication rate2 monthsurease breath test

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026