Third-line H. pylori eradication therapy with sitafloxacin-including regime
Phase 2
- Conditions
- Patients with H. pylori eradication failure after the second-line regimen
- Registration Number
- JPRN-UMIN000001558
- Lead Sponsor
- DIvision of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
- Brief Summary
Sitafloxacin-based triple therapy achieved 83.6% (per-protocol) and 78.2% (intention-to-treat) success in eradicating Helicobacter pylori among 78 Japanese patients after clarithromycin-based first-line and metronidazole-based second-line triple therapies failed. Eradication succeeded in 32 out of 43 patients, even with gyrA mutation-positive Helicobacter pylori (per protocol). The position of the gyrA mutation (N87 or D91) was determined to be a better marker than MIC levels for predicting outcomes of sitafloxacin-based treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
penicillin or quinolone allergy rabeprazole allergy severe liver dysfunction, renal dysfunction pregnancy or possibly pregnancy cases with unsuitable recognition by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Eradication rate of H. pylori by sitafloxacin-including regimen
- Secondary Outcome Measures
Name Time Method MIC of sitafloxacin, gyrA mutation of H. pylori