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

NCT03583476 | Unknown

• 1 other identifier: 201804076RIND
• Study Type: observational
• Target: 1,821
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Resistance; Minimal inhibitory concentration; Treatment efficacy

Outcome Measures

Primary Outcomes (1)

• Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC).

  4 weeks after treatment finished.

Study Arms (4)

CLA triple therapy

Patients with clarithromycin-containing triple therapy

Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

MET triple therapy

Patients with metronidazole-containing triple therapy

Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Concomitant therapy

Patients with concomitant therapy

Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Sequential therapy

Patients with sequential therapy

Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

Interventions

Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole DRUG

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

CLA triple therapy; Concomitant therapy; MET triple therapy; Sequential therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical Center

You may qualify if:

• patients (aged ≥ 20 years old) with H. pylori infection between Jan. 1994 to Mar. 2018

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Tzu-Chi Lai

Taipei, No.33, Linsen S. Rd., Zhongzheng Dist, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Proton Pump Inhibitors; Metronidazole

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Tzu-Chi Lai, Master

CONTACT

886233668791; b01403056@g.ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 11, 2018
• Study Start: April 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)