Helicobacter Pylori Infection | Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection
Helicobacter Pylori Infection research study
What is the primary objective of this study?
Successful H. pylori eradication therapy remains a challenge in medical practice. Despite promising data for first-line, second-line and rescue treatment options based on clinical trials as well as guidelines and expert recommendations, success rates can often not be reproduced in general practice. Rescue options for patients with failed initial or second-line therapy are definitely needed. The new fluoroquinolone moxifloxacin may represent an effective and save treatment option (in combination with a PPI and amoxicillin) for rescue therapy of H- pylori positive patients.However, optimal duration of therapy (7-day course vs 14-day course) has to be determined
Who is eligible to participate?
Inclusion Criteria: - male/female, age >/=18 years - Helicobacter pylori infection proven by histology and culture - indication for eradication therapy according to the Maastricht-III - at least one failed prior eradication attempt - pretherapeutic resistance testing (culture) - written informed consent Exclusion Criteria: - in vitro resistance to moxifloxacin or amoxicillin - current complicated peptic ulcer disease - daily intake of NSAIDs - co-medication with drugs known to interact with the study medication - history of gastric surgery/vagotomy - medical treatment for depression, known suicide attempt - severe cardiological diseases such as bradyarrythmia, QT changes - malignant disease - gravidity, nursing - women with child bearing potential must perform contraceptive measures
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Helicobacter Pylori Infection
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2007
Completed Date: February 2008
Phase: Phase 3
Primary Outcome: Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection.
Secondary Outcome: Tolerability,safety, post treatment resistance, influence of host genetics (CYP status) and pathogenicity factors of H. pylori on treatment success.
Study sponsors, principal investigator, and references
Principal Investigator: Stephan Miehlke, MD, PhD
Lead Sponsor: Technische Universität Dresden
Morgner A, Labenz J, Miehlke S. Effective regimens for the treatment of Helicobacter pylori infection. Expert Opin Investig Drugs. 2006 Sep;15(9):995-1016. Review.