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

NCT ID: NCT03583476

Last Updated: 2018-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CLA triple therapy

Patients with clarithromycin-containing triple therapy

Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Intervention Type DRUG

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

MET triple therapy

Patients with metronidazole-containing triple therapy

Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Intervention Type DRUG

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

Concomitant therapy

Patients with concomitant therapy

Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Intervention Type DRUG

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

Sequential therapy

Patients with sequential therapy

Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Intervention Type DRUG

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

Interventions

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Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tzu-Chi Lai

Taipei, No.33, Linsen S. Rd., Zhongzheng Dist, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tzu-Chi Lai, Master

Role: CONTACT

886233668791

Facility Contacts

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Tzu-Chi Lai, Master

Role: primary

Other Identifiers

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201804076RIND

Identifier Type: -

Identifier Source: org_study_id

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