Goal of study: goal of this study is to evaluate Levofloxacin based versus Clarithromycin based regimes, efficacy in eradication of Helicobacter Pylori (HP) infection. Designing of study: single center randomized, clinical trial. Inclusion criteria to this study: all patients undergoing upper endoscopic procedure with positive rapid urease test (RUT). Exclusion criteria from this study: pregnancy; Previous consumption proton pump inhibitors (PPI) or Bismuth in the preceding one month; Gastrointestinal (GI) bleeding; consumption of alcohol or substance; advanced chronic diseases; lack of willingness to continue the treatment; suffering from any disease needing to consume another antibiotic or non-steroidal anti-inflammatory drugs (NSAIDs). Sample size: 120 patients. Methods & Intervention: patients with upper gastrointestinal symptoms who need endoscopic procedure and their RUT are positive for HP are entered into this study, divided into 2 groups. First group (A) will be treated by Levofloxacin (500mg daily) plus Amoxicillin (1 gr twice a day) plus Omeprazole (20 mg daily) for 2 weeks. Second group (B) will be treated by Clarithromycin (500mg twice a day) plus Amoxicillin (1 gr twice a day) plus Omeprazole (20 mg daily) for 2 weeks. After complementary the main course of treatment they will receive maintenance 4 weeks with omeprazole. After two weeks of not taking any medicine mentioned before every patient will be tested by stool antigen. Ultimately eradication rate of HP will be compared in two groups. Intervention time: 2 weeks Primary outcome: Compare eradication of HP infection by stool antigen of HP between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081818124N2
Registration date:2015-12-23, 1394/10/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Ali Akbar Hajiaghamohammadi
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 0084
Email address
ahmohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to comparing the efficacy of Levofloxacin versus Clarithromycin on eradication of Helicobacter Pylori infection
Public title
Levofloxacin effect on eradication of Helicobacter Pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria to this study: all patients undergoing upper endoscopic procedure with positive rapid urease test (RUT). Exclusion criteria from this study: pregnancy; Previous consumption proton pump inhibitors (PPI) or Bismuth in the preceding one month; Gastrointestinal (GI) bleeding or any complication of peptic ulcer disease (PUD); consumption of alcohol or substance; advanced chronic disease: Diabetes mellitus, Hypertension, Cirrhosis, Cerebrovascular attack, Renal insufficiency, Coronary artery disease and gastric cancer; lack of willingness to continue the treatment; lack of willingness to complete the period of treatment; suffering from any disease needing to consume another antibiotic or non-steroidal anti-inflammatory drugs (NSAIDs).
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
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
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Bahonar Blvd, Qazvin
City
Qazvin
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
9943
Health conditions studied
1
Description of health condition studied
Helicobacter Pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori
Primary outcomes
1
Description
Eradication of Helicobacter Pylori infection
Timepoint
Two months after beginning of treatment
Method of measurement
Primary evaluation of Helicobacter Pylori infection is based on rapid urease test and then eradication will be assessed by Helicobacter Pylori stool antigen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group will take 20 mg of Omeprazole capsule once daily, 1000 mg Amoxicillin capsule two times a day and 500 mg tablet of Levofloxacin once daily. Then Omeprazole will be continued for another 4 weeks.
Category
Treatment - Drugs
2
Description
Control group will take 20 mg Omeprazole Capsule once daily, 1000 mg capsule of Amoxicillin and Clarithromycin 500 mg capsule two times a day. Then Omeprazole will be continued for another 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat hospital, Qazvin
Full name of responsible person
Dr. Ali Akbar Haj Agha Mohammadi
Street address
Velayat hospital, Taavon Sq, Minoodar, Qazvin
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Haj Agha Mohammadi
Street address
Velayat hospital, Taavon Sq, Minoodar, Qazvin
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Haj Agha Mohammadi
Position
Associated professor, Gastroenterologist
Other areas of specialty/work
Street address
Velayat hospital, Taavon Sq, Minoodar, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3379 0623
Fax
Email
Ahmohammadi@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Saeed Safarnezhad
Position
Assistant of internal medicine
Other areas of specialty/work
Street address
Velayat hospital, Taavon Sq, Minoodar, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3379 0625
Fax
Email
Saeed_safarnezhad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Saeed Safarnezhad
Position
Assistant of internal medicine
Other areas of specialty/work
Street address
Velayat hospital, Taavon Sq, Minoodar, Qazvin
City
Qazvin
Postal code
Phone
+98 28 3379 0625
Fax
Email
Saeed_safarnezhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)