Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05475431
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2022-07-24
Brief Title:
Real-world Treatment of H Pylori Eradication in Patients With Comorbidity
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Real-world_Hp
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
Detailed Description:
There is a challenge for eradicating Helicobacter pylori H pylori because the resistant strains of H pylori are increasing In order to overcome the challenge the new regimens are developed including 14-day triple therapy 10-day sequential therapy 10-day bismuth-based quadruple therapy 10-day concomitant therapy or 14-day hybrid therapy which have 8499 of successful eradication rates Additionally there is a new challenge ie worldwide population aging and increases in the proportion of patients with comorbidity 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 Our previous study showed that the eradication rate of 10-day clarithromycin-based sequential therapy was 81 in diabetic patients lower than 87 in non-diabetic patients in other study Therefore 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 The former is because patients may use macrolides because of chronic obstructive pulmonary disease with airway infection for example The latter is because the regimen of H pylori eradication is complex either three or four varieties of pills and dosage intervals for administration Moreover the patients may have taken many other medications for their underline comorbidity These medications may have drug-drug interaction with the H pylori eradication regimen or make the medication adherence poor Most of studies which were conducted in academic institutes patients took the H pylori eradication regimen under the study staffs instruction and monitor however in the real world their medication adherence for H pylori eradication may be compromised 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None