Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial
Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major
causes of ulcers and cancers. Up to 20% of patients infected with HP may develop peptic
ulcers. However, failure rate is rising due to multiple resistant HP infection. The
eradication rate of first line clarithromycin based therapy has fell to below 80% and
increasing number of patients also failed the second line quadruple therapy. The aim of this
clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a
10-day quadruple therapy versus sequential therapy as empirical first and second line
treatment.
Methods: Eligible H. pylori positive patients were randomized to receive either QUAD
(esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline
500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ
(esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days,
clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent
5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test
(UBT) to confirm eradication. Patients who failed their respective therapy were crossover to
receive the alternative regimen.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Helicobacter pylori eradication rate
Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test
8 weeks after treatment
No
Ivan FN Hung, MD FRCP
Principal Investigator
The University of Hong Kong
Hong Kong: Ethics Committee
UW 11-221
NCT01760824
May 2011
December 2012
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