Concomitant Versus Hybrid Regimen for H. Pylori Eradication (NCT03592069) | Clinical Trial Compass
CompletedPhase 4
Concomitant Versus Hybrid Regimen for H. Pylori Eradication
Greece345 participantsStarted 2018-02-21
Plain-language summary
10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria:
* patients of 18 years or older referring for upper GI endoscopy
* infected with H. pylori (verified with 2 out of 3 tests - rapid urease test, histology, culture)
* without previous H. pylori eradication treatment (naĂ¯ve)
Exclusion criteria are:
* age below 18 years
* presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, cardiovascular or pulmonary disease)
* previous gastric surgery
* gastric malignancies
* Zollinger-Elisson syndrome
* known allergy or other contraindications to the study medications
* previous H. pylori treatment
* use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month
* use of PPI in the preceding two weeks
* not willing to participate in the study
* pregnant or lactating women
What they're measuring
1
To compare eradication rates between a 10 day concomitant and a 14 day hybrid regimens in intention to treat and per protocol analyses