Clinical trial
The Most Appropriate Prescription of the First-line, the Second-line, and the Third Treatment for H. Pylori Eradication Among Patients Who Are Comorbid Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, or Chronic Kidney Disease
Name
B-ER-109-072
Description
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.
Trial arms
Trial start
2020-05-06
Estimated PCD
2023-12-31
Trial end
2023-12-31
Treatment
The sequential therapy
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
Arms:
The Charlson scores < 2, The Charlson scores >= 2
The triple therapy
Proton pump inhibitors, amoxicillin, and clarithromycin for 7, 10, or 14 days.
Arms:
The Charlson scores < 2, The Charlson scores >= 2
The hybrid therapy
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 .
Arms:
The Charlson scores < 2, The Charlson scores >= 2
The concomitant therapy
Proton pump inhibitors, amoxicillin, clarithromycin, and metronidazole for a total of 7 or 14 days
Arms:
The Charlson scores < 2, The Charlson scores >= 2
Bismuth-based quadruple therapy
Proton pump inhibitors, bismuth, tetracycline, and metronidazole for a total of 10 or 14 days
Arms:
The Charlson scores < 2, The Charlson scores >= 2
Size
1000
Primary endpoint
The eradication rate by the intention-to-treat analysis
At least six weeks after the completion of H. pylori eradication
The eradication rate by the per-protocol analysis
At least six weeks after the completion of H. pylori eradication
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients are excluded if they ever received H. pylori eradication before.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}
Updated at
2023-10-03
1 organization
5 products
6 indications
Organization
National Cheng-Kung University HospitalProduct
The sequential therapyIndication
Helicobacter pylori infectionIndication
Comorbidities and Coexisting ConditionsIndication
Real-world OutcomeIndication
AdherenceIndication
Medication AdherenceIndication
Patient DropoutsProduct
The triple therapyProduct
The Hybrid TherapyProduct
The concomitant therapy