Real-world Treatment of H. Pylori Eradication in Patients with Comorbidity

NCT05475431 | Completed

• 1 other identifier: B-ER-109-072
• Study Type: observational
• Target: 1,053
• Locations: 1 country
• Sites: 2

Brief Summary

Most of the studies of H. pylori eradication were conducted in academic institutes and designed to enrolled patients who did not have comorbidities. However, patients in the real world may comorbid with diabetes, chronic obstructive pulmonary disease, cirrhosis, chronic kidney diseases, or others. We hypothesize that the eradication rate of H. pylori in patients with comorbidity is poor because they may be infected with antibiotics-resistant H. pylori strains or have poor medication adherence. Here, we design a study, which focus on the H. pylori eradication rates by the various regimens in the real world, especially for those with high Charlson scores. It is presumed that our data will be helpful with regard to treating such patients with H. pylori eradication in the clinical scenario.

Conditions

Helicobacter Pylori Infection; Comorbidities and Coexisting Conditions; Real-world Outcome; Medication Adherence; Patient Compliance; Patient Dropouts

Keywords

Helicobacter pylori; Comorbidity; Patient dropouts; Medication adherence

Outcome Measures

Primary Outcomes (2)

• The eradication rate by the intention-to-treat analysis

  Successful H. pylori eradication is confirmed by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test. All the reviewed patients are analyzed for intention-to-treat of H. pylori eradication.

  At least six weeks after the completion of H. pylori eradication

• The eradication rate by the per-protocol analysis

  Successful H. pylori eradication is confirmed by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test. Patients who do not complete the regimens or do not receive the confirmation of successful H. pylori eradication by the 13C-urea breath test, rapid urease test, or H. pylori stool antigen test are excluded from the per-protocol analysis.

  At least six weeks after the completion of H. pylori eradication

Study Arms (2)

The Charlson scores >= 2

Patients who are \>= 20 years and diagnosed with H. pylori infection either by rapid urease test or by histology from January 1, 2012 to December 31, 2019 are reviewed retrospectively. Patients are excluded if they ever received H. pylori eradication before. Patient characteristics, including age, sex, and the parameters of the Charlson scores, are recorded and analyzed. Moreover, the tablet number and varieties of medications patients took for underlying diseases are also recorded. If the patients' Charlson scores \>= 2, they are divided into the Charlson scores \>= 2 group.

Drug: The sequential therapy; Drug: The triple therapy; Drug: The hybrid therapy; Drug: The concomitant therapy; Drug: Bismuth-based quadruple therapy

The Charlson scores < 2

Patients who are \>= 20 years and diagnosed with H. pylori infection either by rapid urease test or by histology from January 1, 2012 to December 31, 2019 are reviewed retrospectively. Patients are excluded if they ever received H. pylori eradication before. Patient characteristics, including age, sex, and the parameters of the Charlson scores, are recorded and analyzed. Moreover, the tablet number and varieties of medications patients took for underlying diseases are also recorded. If the patients' Charlson scores \< 2, they are divided into the Charlson scores \< 2 group.

Drug: The sequential therapy; Drug: The triple therapy; Drug: The hybrid therapy; Drug: The concomitant therapy; Drug: Bismuth-based quadruple therapy

Interventions

The sequential therapy DRUG

Proton pump inhibitors and amoxicillin for the first 5 or 7 days and sequent proton pump inhibitors, clarithromycin, and metronidazole for the next 5 or 7 days

The Charlson scores < 2; The Charlson scores >= 2

The triple therapy DRUG

Proton pump inhibitors, amoxicillin, and clarithromycin for 7, 10, or 14 days.

The Charlson scores < 2; The Charlson scores >= 2

The hybrid therapy DRUG

Proton pump inhibitors and amoxicillin starting from the 1st day and for a total of 10 or 14 days, and clarithromycin, and metronidazole starting from the 8th day and for a total of 7 days .

The Charlson scores < 2; The Charlson scores >= 2

The concomitant therapy DRUG

Proton pump inhibitors, amoxicillin, clarithromycin, and metronidazole for a total of 7 or 14 days

The Charlson scores < 2; The Charlson scores >= 2

Bismuth-based quadruple therapy DRUG

Proton pump inhibitors, bismuth, tetracycline, and metronidazole for a total of 10 or 14 days

The Charlson scores < 2; The Charlson scores >= 2

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is conducted at the outpatient department of National Cheng Kung University Hospital in Tainan, Taiwan. Patients who are diagnosed with H. pylori infection and receive H. pylori eradication in the hospital are the candidates to be reviewed.

You may qualify if:

• Patients who are \>= 20 years and received the therapy for H. pylori eradication from January 1, 2012 to December 31, 2019 are reviewed retrospectively. The regimens include 10- or 14-day sequential therapy, 7-, 10-, or 14-day triple therapy, 10- or 14-day hybrid therapy, 7- or 14-day concomitant therapy, 10- or 14-day bismuth-based quadruple therapy.

You may not qualify if:

• Patients are excluded if they ever received H. pylori eradication before.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Health and Welfare, Taiwan: collaborator

Study Sites (2)

National Cheng Kung University Hospital

Tainan, Taiwan, 704302, Taiwan

Location

Helicobacter pylori study group, National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

MeSH Terms

Conditions

Medication Adherence; Patient Compliance; Patient Dropouts

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: July 27, 2022
• Study Start: May 6, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 7, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)