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

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National Taiwan University

Status

Unknown

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Study type

Observational

Funder types

Other

Identifiers

NCT03583476
201804076RIND

Details and patient eligibility

About

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.

Enrollment

1,821 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,821 participants in 4 patient groups

CLA triple therapy
Description:
Patients with clarithromycin-containing triple therapy
Treatment:
Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole
MET triple therapy
Description:
Patients with metronidazole-containing triple therapy
Treatment:
Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole
Concomitant therapy
Description:
Patients with concomitant therapy
Treatment:
Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole
Sequential therapy
Description:
Patients with sequential therapy
Treatment:
Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Trial contacts and locations

1

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Central trial contact

Tzu-Chi Lai, Master

Data sourced from clinicaltrials.gov

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