Esomeprazole, Moxifloxacin and Amoxicilin for Rescue Therapy of Helicobacter Pylori Infection

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
Successful H. pylori eradication therapy remains a challenge in medical practice. Currently, a PPI - based triple therapy containing clarithromycin, amoxicillin or nitroimidazole given for 7 days is the recommended first line treatment approach with an expected eradication success rate of approximately 80%. As second-line treatment option in case of failure, a RBC-based quadruple therapy is currently recommended curing another 80% of patients, leaving a subset of patients with persistent H. pylori infection. Resistance to fluoroquinolones is low in most countries,hence these compounds are potential candidates for second-line and rescue treatment. The new fluoroquinolone moxifloxacin launched by Bayer in 1999 for the treatment of respiratory tract infections, has a broad antibacterial spectrum comparable to levofloxacin but fewer phototoxic and central nervous system excitatory effects. The possible role of moxifloxacin in H. pylori eradication is since under clinical investigation

Official Title
-----------------
Randomized, Controlled, Multicenter Phase III Study for the Efficacy and Tolerability of Triple Therapy With Esomeprazole, Moxifloxacin and Amoxicillin for Rescue Therapy of Helicobacter Pylori Infection

Conditions
-----------------
Helicobacter Pylori Infection, Chronic Gastritis

Intervention / Treatment
-----------------
* Drug: esomeprazole
* Drug: moxifloxacin
* Drug: amoxicillin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: esomeprazole|nan|
|Drug: moxifloxacin|nan|
|Drug: amoxicillin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of a combination of esomeprazole (E), moxifloxacin (M) and amoxicillin (A) for third line therapy of H. pylori infection. |  |  | 
| Comparison of EMA 7 days versus EMA 14 days. Hypothesis: superiority of EMA 14 days 4 weeks after end of eradication therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability,safety, post treatment resistance, influence of host genetics (CYP status) and pathogenicity factors of H. pylori on treatment success. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, rescue therapy, eradication therapy, esomeprazole, moxifloxacin, resistance