Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Study Overview
=================
Brief Summary
-----------------
Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.

Official Title
-----------------
Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease

Conditions
-----------------
Helicobacter Pylori Infection, Intravenous Drug Usage

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Metronidazole
* Drug: Levofloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged between 18 and 75 years old Without previous Helicobacter pylori treatment Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination Ability and willingness to participate in the study and to sign and give informed consent Positive for Helicobacter pylori IgM antibody Exclusion Criteria: With previous gastric surgery Major systemic diseases Pregnancy or lactation Allergy to any of the study drugs Decline to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous therapy<br>Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks. | Drug: Esomeprazole<br>* Proton pump inhibitor<br>Drug: Metronidazole<br>* antibiotic for H. pylori eradication<br>Drug: Levofloxacin<br>* antibiotic for H. pylori eradication<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value). | Six weeks after completion of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse effects |  | Within 7 days after completion of therapy | 
| Rate of stop bleeding |  | Within 7 days after completion of therapy | 
| Rate of pyloric obstruction remission |  | Within 7 days after completion of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter Pylori Infection, Intravenous Drug Usage