FindTrial
Sign In

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002639-26-DE
Enrollment
Unknown
Registered
2007-01-25
Start date
2007-01-10
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic, H. pylori-infected male and female patients 16 µg/ml

Interventions

Trade Name: Amoxicillin-ratiopharm 500 Pharmaceutical Form: Tablet INN or Proposed INN: Amoxicillin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Symptomatic, H. pylori-infected male and female patients 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

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)

Design outcomes

Primary

MeasureTime frame
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 To investigate whether the success rate is dependent on the dose expressed as mg/kg bodyweight ;Primary end point(s): The primary endpoint is efficacy: successfull eradication of Helicobacter pylori after 14 days of therapy—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026