The Impact of Antibiotics MIC Value on the Efficacy of Treatment Regimens for Helicobacter Pylori Infection.

Study Overview
=================
Brief Summary
-----------------
Clarithromycin (CLA)、amoxicillin (AMO)、metronidazole (MET)、levofloxacin (LEV) and tetracycline (TET) are commonly used antibiotics for Helicobacter pylori (Hp) therapy. However, the efficacy of treatment for Helicobacter pylori infection has decreased due to increasing resistance to CLA, MET and LEV. Studies had reported that beside antibiotics resistance, other factors such as age, sex, underlying disease, etc. may also affect the treatment efficacy. In some cases, when the MIC values were beyond the breakpoint, H. pylori strains with lower MIC value had better eradication than the ones with higher MIC value. However, few study investigated the relationship between MIC values and treatment outcome. The investigators aimed to analyze the impact of influencing factors, especially minimal inhibitory concentration (MIC) value, on the efficacy of different treatment regimens.

Official Title
-----------------
The Impact of Antibiotics MIC Value on the Efficacy of Treatment Regimens for Helicobacter Pylori Infection.

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients (aged ≥ 20 years old) with H. pylori infection between Jan. 1994 to Mar. 2018 Exclusion Criteria: without antibiotics susceptible test result, without treatment outcome, history of any gastrointestinal surgery, serious concomitant (renal failure, liver cirrhosis, heart failure and disease need immunosuppressant for therapy.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLA triple therapy<br>Patients with clarithromycin-containing triple therapy | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole<br>* Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.<br>|
| MET triple therapy<br>Patients with metronidazole-containing triple therapy | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole<br>* Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.<br>|
| Concomitant therapy<br>Patients with concomitant therapy | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole<br>* Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.<br>|
| Sequential therapy<br>Patients with sequential therapy | Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole<br>* Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC). |  | 4 weeks after treatment finished. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Helicobacter pylori, Resistance, Minimal inhibitory concentration, Treatment efficacy