Evaluation of H pylori eradication rate with 14-days levofloxacin,amoxicillin&pantoprazole regimen and its comparison with standard regimen of clarithromycin,amoxicillin &pantoprazole in patients of gastrointestinal clinic
Determination of H pylori eradication rate with 14-days levofloacin,amoxicillin&pantoprazol regimen and its comparison with standard regimen of clarithromycin,amoxicillin &pantoprzol in patients of GI clinic (kerman-2017) and its relation with patients age and sex
Design
Urease positive patients are divided randomly into two equal groups(each group 85 patient and totally 170 patient) and each group are treated with one of abovementioned A or B antibiotic regimens for 14 days
Settings and conduct
This study determines the eradication rate of gastric H.pylori infection with two combination triple therapy regimens :A and B ,and compare them with each other. Patients aged 18 to 65 with upper abdominal symptoms in gastrointestinal clinic of Kerman University of Medical Sciences in 2017 undergo upper endoscopy if indicated (according to GI disease references) and rapid urease test on gastric mucosa is done for them to evaluate helicobacter pylori infection
Participants/Inclusion and exclusion criteria
Exclusion criteria;ppi consumption in 2 wks ago ;antibiotic use in 4 wks ago;GI bleeding ;allergy to antibiotics ;drug intolerance ;unresponsiveness to standard clarithromycin regimen( duo to ethic consideration)
Inclusion criteria:ages between18 and 65 with epigastric complaints
Intervention groups
Regimen A includes levofloxacin,amoxicillin and pantoprazole. Regimen B includes clarithromycin, amoxicillin and pantoprazole. The duration of treatment is 14 days for both regimens
Main outcome variables
One month later ,stool antigen test will be done to determine the eradication rate of helicobacter infection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170803035490N1
Registration date:2017-12-04, 1396/09/13
Registration timing:registered_while_recruiting
Last update:2017-12-04, 1396/09/13
Update count:0
Registration date
2017-12-04, 1396/09/13
Registrant information
Name
Masoud Hajmohammadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5709
Email address
m.hajmohammadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
governmental and research fund
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of H pylori eradication rate with 14-days levofloxacin,amoxicillin&pantoprazole regimen and its comparison with standard regimen of clarithromycin,amoxicillin &pantoprazole in patients of gastrointestinal clinic
Public title
Gastric Helicobacter pylori infection eradication rate with levofloxacin based regimen and comparison with standard clarithromycin regimen
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age from 18 to 65 yrs
With epigastric problems
Exclusion criteria:
PPI consumption in 2 wks ago
Antibiotic use in 4 wks ago
GI bleeding
Allergy to antibiotics
Drug intolerance
Unresponsiveness to standard clarithromycin regimen( duo to ethic consideration)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization : block,Unit of randomization : individual,Tools used in randomization : table of random numbers
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
Kerman Univercity of Medical Sciences
Street address
Univercity Campus, Haftbagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2016-09-05, 1395/06/15
Ethics committee reference number
IR.KMU.AH.REC.1395.42
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Helicobacter pylori eradication rate in stomach
Timepoint
One month after therapy
Method of measurement
Stool antigen test
Secondary outcomes
1
Description
drug side effects
Timepoint
during and after intervention
Method of measurement
monitoring for side effects
Intervention groups
1
Description
Levofloxacin:250 mg po Bid ,
Amoxicillin:1 gr po Bid,
Pantoprazole:40 mg po Bid
14 days
Category
Treatment - Drugs
2
Description
Clarithromycin:500 mg po Bid ,
Amoxicillin:1gr po Bid ,
Pantoprazole :40 mg po Bid ,
14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Clinic 1
Full name of responsible person
Dr Bijan Ahmadi
Street address
Tahmasbabad Crossway, Shariati Street
City
Kerman
Province
Kerman
Postal code
13555 76169
Phone
+98 34 3226 8740
Email
besatclinic@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Vice-Chancellor for Research Building, tahmasbabad Crossway, Shariati Streeti
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3815
Email
kmu_research@yhoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr Bijan Ahmadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Street address
Afzalipor Hospital, Emam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
Email
Ay_bijan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Bijan Ahmadi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Afzalipor Hospita, Emam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
+98 34 3325 7770
Email
Ay_bijan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Masoud Hajmohammadi
Position
Resident of Internal Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Afzalipor Hospital, Emam Highway,
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Fax
+98 34 3325 7770
Email
Masoudjmd@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available