Comparison of triple treatment regimen containing levofloxacin with triple treatment regimen containing clarithromycin in the first line of treatment of patients with Helicobacter pylori infection referred to the clinic of Imam Khomeini Hospital during 2021-2022.
The main objectives of the project:
Comparison of triple treatment regimen containing levofloxacin with triple treatment regimen containing clarithromycin in the first line of treatment of patients with Helicobacter pylori infection
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 3 on 130 patients. A table of four blocks was used for randomization.
Settings and conduct
Gastroenterology Clinic of Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Confirmation of the presence of H.pylori by fecal antigen test
Intervention groups
Group 1: Triple treatment regimen containing levofloxacin in Helicobacter pylori eradication
Group 2: Triple treatment regimen containing clarithromycin in eradication of Helicobacter pylori
Comparison of triple treatment regimen containing levofloxacin with triple treatment regimen containing clarithromycin in the first line of treatment of patients with Helicobacter pylori infection referred to the clinic of Imam Khomeini Hospital during 2021-2022.
Public title
Comparison of two antibiotic regimens in eradicating Helicobacter pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of the presence of H.pylori by fecal antigen test
Exclusion criteria:
History of previous treatment for eradication of Helicobacter pylori
Age less than 18 years and over 65 years
History of allergy or severe reaction to drugs used in the plan
History of major surgery on the gastrointestinal tract such as bilirut and bypass and gastrogenostomy And gastrectomy
Severe underlying disease such as liver failure) Cirrhosis of the liver (or kidney) Creatinine above 2 (or proven malignancy Untreated active
Active pregnancy or lactation
Inability to follow up
Use of proton pump inhibitors And antibiotics in the last 4 weeks
Contraindications to the use of prescription drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
According to the list, he receives one of two antibiotic regimens. The random list in the clinic is numbered from 1 to 130. In front of each number, one of the antibiotic regimens is written and the patients receive the intervention group or the control group according to the list of one of the two regimens. The list consists of four blocks, in each block, there are two intervention groups and two control groups that are randomly arranged inside the block. The blocks themselves were also randomly placed in the list. Random allocation at each stage is done by the methodologist.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Gastroenterology Department،; Imam Khomeini Hospital Complex، Dr. Gharib Street، Keshavarz Boulevard، tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2021-04-19, 1400/01/30
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.041
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Negative stool antigen test for Helicobacter pylori infection at the end of treatment
Timepoint
2 months and 10 days after starting treatment
Method of measurement
Stool antigen test for Helicobacter pylori infection
Secondary outcomes
1
Description
Adherence to treatment
Timepoint
11 days after starting treatment
Method of measurement
questionnaire
2
Description
Complications of treatment
Timepoint
11 days after starting treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Levofloxacin 500 mg daily, amoxicillin 1 g twice daily and omeprazole 20 mg twice daily for 10 days, then omeprazole 20 mg daily for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: clarithromycin 500 mg, amoxicillin 1 g and omeprazole 20 mg all twice a day for 10 days then 4 weeks daily omeprazole 20 mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mohamad Taher
Street address
Gastroenterology Department،; Imam Khomeini Hospital Complex، Dr. Gharib Street، Keshavarz Boulevard، Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2987
Email
ms-nasirit@student.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Ali Sahraian
Street address
Gastroenterology Department،; Imam Khomeini Hospital Complex، Dr. Gharib Street، Keshavarz Boulevard، Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2987
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Taher
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology Department،; Imam Khomeini Hospital Complex، Dr. Gharib Street، Keshavarz Boulevard، Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2987
Email
ms-nasirit@student.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Taher
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology Department،; Imam Khomeini Hospital Complex، Dr. Gharib Street، Keshavarz Boulevard، Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2987
Email
ms-nasirit@student.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Seraj Nasiri Toosi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Others
Street address
Gastroenterology Department،; Imam Khomeini Hospital Complex، Dr. Gharib Street، Keshavarz Boulevard، Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2987
Email
ms-nasirit@student.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD