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

Conditions: 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.

Registration Number: EUCTR2006-002639-26-DE

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

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-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

Exclusion Criteria

-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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the eradication rates with an increased dose triple therapy (esomeprazole + amoxicillin + esomeprazole), both given for 14 days in pediatric patients infected with a Helicobacter pylori strain resistant to metronidazole & clarithromycin.;Secondary Objective: To evaluate the rate of adverse events and<br>To investigate whether the success rate is dependent on the dose expressed as mg/kg bodyweight<br>;Primary end point(s): The primary endpoint is efficacy: successfull eradication of Helicobacter pylori after 14 days of therapy

Secondary Outcome Measures