N/A
N=164
Levofloxacin-containing Therapies In Second Line Helicobacter Pylori Eradication
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT02596620 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Percentage of Participants With Successful Eradication of H. Pylori — 91.4; 81.5 percentage of eradication
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nexium (Drug); Amolin (Drug); Cravit (Drug); Flagyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Eradication of H. Pylori |
91.4; 81.5 | — |
Summary
Asia Pacific Consensus states that levofloxacin-based triple therapy as an alternative second-line therapy after Helicobacter pylori (H. pylori) eradication failure when bismuth salts are not available. The investigators compare the efficacies of 10-day levofloxacin-based sequential therapy and 10-day triple therapy in the treatment for patients after failure of standard triple therapy and to determine what clinical and bacterial factors influencing the efficacy of salvage regimens.
Eligibility Criteria
Inclusion Criteria
- Consecutive H. pylori-infected participants, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis who failed first-line eradication therapies with standard triple regimens (PPI twice daily, 500 mg of clarithromycin twice daily and 1 g of amoxicillin twice daily)
Exclusion Criteria
- Ingestion of antibiotics, bismuth, or proton-pump inhibitors within the prior 4 weeks
- Use of non-steroidal anti-inflammatory drugs within the prior 4 weeks
- Participants with allergic history to the medications used
- Participants with previous gastric surgery
- The coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
- Pregnant women.
Data sourced from ClinicalTrials.gov (NCT02596620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.