GASTRITIS Clinical Trial
Official title:
Efficacy of Levofloxacin-Doxycycline Based Rescue Therapy for Helicobacter Pylori Eradication: A Prospective Open-label Trial in Saudi Arabia
Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy.
Different second-line therapeutic options are available. However, the success of second-line
therapy has not been addressed or reported from Saudi Arabia.
Objectives The primary objective was to evaluate the efficacy of the 10-day course of
levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H.
pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to
treatment, factors associated with eradication of H. pylori and adverse events associated
with the treatment.
A prospective, open-label, single arm study was conducted. Patients were recruited from a tertiary care hospital in Saudi Arabia from June 2013 to April 2014. A total of 55 patients had previously received standard triple therapy and/or sequential therapy in the period from 2011 to 2014 and failed to eradicate the infection. The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily. Urea-breath-test (UBT) was done at a minimum of 6 weeks after completion of the treatment to confirm the H. pylori eradication. Compliance and tolerability of the regimen were also assessed. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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