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

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.

Study Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole

• Study Type: Observational
• Enrollment (Anticipated): 1821

Contacts and Locations

Study Locations

• Taiwan
  • No.33, Linsen S. Rd., Zhongzheng Dist
    • Taipei city, No.33, Linsen S. Rd., Zhongzheng Dist, Taiwan, 100
      • Recruiting
      • Tzu-Chi Lai
      • Contact: Tzu-Chi Lai, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medical Center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CLA triple therapy; Patients with clarithromycin-containing triple therapy	Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole; Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.
MET triple therapy; Patients with metronidazole-containing triple therapy	Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole; Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.
Concomitant therapy; Patients with concomitant therapy	Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole; Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.
Sequential therapy; Patients with sequential therapy	Drug: Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole; Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Resistance; Treatment efficacy; Minimal inhibitory concentration
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Amoxicillin; Clarithromycin; Proton Pump Inhibitors
• Other Study ID Numbers: 201804076RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No