Comparison of the efficacy of a levofloxacin-tetracycline-based quadriple regimen with a clarithromycin-based regimen to eradicate Helicobacter pylori infection
Comparison of the efficacy of levofloxacin-tetracycline-based four-agents regimen with clarithromycin-based diet in eradicating Helicobacter pylori infection
Design
After selecting the patients, a written consent form is given to the patients and while explaining about the side effects and results of taking the drugs, the patient enters the study. The patient can be excluded from the study at any time, depending on his choice.
The duration of these treatment regimens is two weeks, and after the end of antibiotic treatment, treatment with pantoprazole 40 mg bid for four weeks is continued for both groups, and then at the end of the second week after the end of treatment with fecal antigen test will prove .
Settings and conduct
The study site is the gastrointestinal clinic of Imam Khomeini Hospital in Ahvaz
Participants/Inclusion and exclusion criteria
Patients are selected based on clinical complaint and endoscopy, positive RUT test, no previous treatment for H. pylori infection, and no quinolone and macrolide antibiotics during the last two months. Inclusion criteria include all patients with PUD, non-ulcer dyspepsia, and intestinal metaplasia (based on pathology) who are H pylori positive and over 18 years of age. Exclusion criteria are also discontinuation of drugs due to drug side effects or for any reason before one week from the start of the drug.
Intervention groups
These people are divided into two groups based on simple randomization method and will receive two different diets to eradicate their H pylori infection: a group of four-agents-based on levofloxacin-tetracycline-group A ,the other group will be given a clarithromycin-based-group B, quadruple -agents.
Main outcome variables
Eradication
drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200707048038N1
Registration date:2020-11-24, 1399/09/04
Registration timing:registered_while_recruiting
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Tahmineh Farbod Ara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8415
Email address
farbodara.t@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of a levofloxacin-tetracycline-based quadriple regimen with a clarithromycin-based regimen to eradicate Helicobacter pylori infection
Public title
Comparison of the efficacy of a levofloxacin-tetracycline-based quadriple regimen with a clarithromycin-based regimen to eradicate Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
selection of patients based on clinical complaint of non-ulcer dyspepsia and endoscopy (confirmation of peptic ulcer or pathological confirmation of intestinal metaplasia or gastritis in the field of H. pylori) with a positive RUT test
no previous treatment for H. pylori infection
no use of quinolone and macrolide antibiotics during the last two months.
over 18 years of age.
Exclusion criteria:
Severe side effects of the drug that lead to discontinuation of the drug before completing one week of treatment
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
192
Randomization (investigator's opinion)
Randomized
Randomization description
These people are based on the method of simple randomization of numbers before starting the study with Random allocation software. No concealment is done for the reader and patients will be assigned to group A or B based on random numbers upon entry.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The diagnosis is based on endoscopic biopsy and rapid urease test (RUT) and is performed by the therapist. After selecting the patients, a written consent form is given to the patients and while explaining about the common side effects and results of taking the drugs, the patient enters the study. The patient can be excluded from the study at any time, depending on his choice. The cost of drugs is provided by the researcher, the drugs are from one brand and will be delivered to the patient. Common side effects leading to discontinuation of the patient or dangerous side effects that require medication should not be continued (for example, nausea and gastrointestinal upset with antibiotics are common, and dangerous side effects such as hypersensitivity reactions, tendonitis). Therefore, in case of leaving the study due to drug side effects, it will be mentioned in the study results. At the end of the fourth week after the treatment, the eradication is confirmed by a stool antigen test, and we will prove the effectiveness of the bacterial eradication treatment. Assessing the patient's acceptance in relation to the correct and complete use of drugs by the therapist and by observing the amount of remaining drugs and asking the patient directly every two weeks by phone and asking about the side effects of drugs, continuing treatment and creating the necessary knowledge about the importance of completing treatment will be done. If the patient takes the full course of fourteen days of antibiotic treatment, it will be considered as a complement to the treatment. All data will be completed in a questionnaire by the therapist (attached at the bottom of the questionnaire).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Golestan Educational and Medical Center, Ahvaz
Street address
Khuzestan Province, Ahvaz Golestan - Farvardin St. - Golestan Educational and Medical Center
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.102
Health conditions studied
1
Description of health condition studied
H 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
Percentage of people with non-ulcer dyspepsia
Timepoint
at initiation of study
Method of measurement
performing upper gastrointestinal endoscopy
2
Description
Percentage of people with intestinal metaplasia
Timepoint
at initiation of study
Method of measurement
performing upper gastrointestinal endoscopy
3
Description
Percentage of people with peptic ulcer disease
Timepoint
at initiation of study
Method of measurement
performing upper gastrointestinal endoscopy
Secondary outcomes
1
Description
H-pylori eradication
Timepoint
after completing treatment
Method of measurement
Stool antigen test for H-pylori
2
Description
Drug side effect
Timepoint
every week
Method of measurement
according to patient
Intervention groups
1
Description
Intervention group: four-agents-based on levofloxacin-tetracycline-group A.Tetracycline-levofloxacin group regimen includes: tetracycline 500 mg every 12 hours, levofloxacin 500 mg daily, bismuth subcitrate 240 mg every 12 hours and pentaprazole 40 mg every 12 hours for 14 days and then pentaprazole at a dose of 40 mg every 12 hours It lasts for four weeks.
Category
Treatment - Drugs
2
Description
Control group: clarithromycin-based-group B, quadruple -agents.. Clarithromycin-amoxicillin regimen includes: clarithromycin 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours, bismuth subcitrate 240 mg every 12 hours, and pentaprazole 40 mg every 12 hours for 14 days, followed by pentaprazole at a dose of 40 mg. Mg every twelve hours for four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Imam Khomeini Hospital in Ahvaz
Full name of responsible person
Tahmineh Farbod Ara
Street address
Azadegan St. - Imam Khomeini Medical Center of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
00986193673166
Phone
+98 61 3222 2922
Fax
+98 61 3222 2922
Email
tfarbodara@gmail.com
Web page address
https://himam.ajums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Ahvaz University City - Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences and Health Services - Ground Floor
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3373 8383
Fax
+98 61 3336 1544
Email
ahmadi-m@ajums.ac.ir
Web page address
https://vchresearch.ajums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Tahmineh Farbod Ara
Position
fellowship of Adult specialist in gastroenterology and adult liver
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ahwaz. Azadegan St. - Imam Khomeini Educational and Medical Center
City
Ahvaz
Province
Khouzestan
Postal code
00986193673166
Phone
0098612222922
Email
tfarbodara@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Tahmineh Farbod Ara
Position
Gastroenterology felowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan St. - Imam Khomeini Medical Center of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
00986193673166
Phone
+98 61 3222 2922
Email
tfarbodara@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Tahmineh Farbod Ara
Position
Gastroenterology fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Azadegan St. - Imam Khomeini Medical Center of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
00986193673166
Phone
+98 61 3222 2922
Email
tfarbodara@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data is entered in an Excel file and is with the reader, and if other researchers wish, it can be accessed by email after submitting the final article.
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For meta-analysis studies only, citing the source
From where data/document is obtainable
Contact the researcher email
pezhmanalavinejad@gmail.com
What processes are involved for a request to access data/document
Contact the researcher email
pezhmanalavinejad@gmail.com