Treatment of Helicobacter pylori infection with high dose esomeprazole, amoxicillin and metronidazole in pediatric patients infected with double resistant Helicobacter pylori strains - HP-DR-STUDIE

Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunersches Kinderspital0 个研究点开始时间: 2007年1月25日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-Symptomatic, H. pylori-infected male and female patients <18 years of age with a positive culture of H. pylori and proven resistance to metronidazole & clarithromycin (E-test or agar diffusion). MIC (minimal inhibitory concentration) breakpoints for resistance are defined as follows: metronidazole >16 µg/ml; clarithromycin >1.0 µg/ml; amoxicillin > 0.5 µg/ml.
•-Body weight >15 kg
•-Informed consent of the patient/parent
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-susceptibility testing was not successful or is missing
•-resistance of the strain against amoxicillin
•-complicated peptic ulcer disease such as bleeding or perforation
•-NSAID use on a regular basis
•-status after gastric resection
•-contraindication for any of the study drugs (esomeprazole, amoxicillin, or metronidazole)
•-pregnancy (a pregnancy test should be performed in female teenagers in case of any possibility of a pregnancy according to the history)
•-severe concomitant disease (e.g. renal or liver insufficiency)

发起方

Klinikum der Universität München, Kinderklinik und Poliklinik im Dr. von Haunersches Kinderspital