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NCT03583476 Clinical Trial

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

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03583476
Other study ID # 201804076RIND
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date December 31, 2018

Study information
Verified date June 2018
Source National Taiwan University Hospital
Contact Tzu-Chi Lai, Master
Phone 886233668791
Email b01403056@g.ntu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1821
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole
Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.

Locations
Country Name City State
Taiwan Tzu-Chi Lai Taipei city No.33, Linsen S. Rd., Zhongzheng Dist

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC). 4 weeks after treatment finished.
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