Comparison of 5-day and 10-day levofloxacin based concomitant regimen to eradication of helicobacter pylori infection
Design
Randomized control trial, parallel group
Settings and conduct
this study is a randomised control trial conducted on patients of Ayatollah Rohani hospital, Babol, Iran who have proven H. pylori infection with histological sample. with respect to inclusion and exclusion criteria, Patients divided in two groups randomly and take levofloxacin based concomitant regimen for 5 or 10 days. Side effects of therapeutic regimen ask from patient during treatment period. H. pylori stool antigen test evaluated 6 weeks after the end of treatment.
Participants/Inclusion and exclusion criteria
inclusion criteria: All patients with the age of 18 to 80 years old with proven Helicobacter pylori infection with histological sample
Exclusion criteria: chronic or severe disease, pregnant patients, taking antibiotics, NSAIDs or proton pump inhibitors over the last month, history of stomach surgery, severe impaired renal (Cr> 2 mg/dl) or hepatic function, gastric cancer, allergy to levofloxacin, amoxicillin, Metronidazole or pantoprazole
Intervention groups
Patients divided in two groups randomly
group A:
Amoxicillin 1 gr twice a day
Levofloxacin 500 mg daily
Metronidazole 500 mg twice a day
Pantoprazole twice a day
all regimen continue for 5 day
group B:
Amoxicillin 1 gr twice a day
Levofloxacin 500 mg daily
Metronidazole 500 mg twice a day
Pantoprazole twice a day
all regimen continue for 10 day
Main outcome variables
evaluation of the response of H.pylori infection treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190405043169N1
Registration date:2019-05-18, 1398/02/28
Registration timing:registered_while_recruiting
Last update:2019-05-18, 1398/02/28
Update count:0
Registration date
2019-05-18, 1398/02/28
Registrant information
Name
Amin Vahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4324 0633
Email address
a.vahedi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 5-day and 10-day levofloxacin-based concomitant regimen to eradication of Helicobacter pylori : A randomized clinical trial
Public title
Comparison of two quadruple regimens to eradication of helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with the age of 18 to 80 years old with proven Helicobacter pylori infection with histological sample
Exclusion criteria:
age lesser than 18 years old or more than 80 years old
taking antibiotics, NSAIDs or proton pump inhibitors over the last month
history of stomach surgery
severe impaired renal (Cr> 2 mg/dl) or hepatic function
gastric cancer
allergy to levofloxacin, amoxicillin, Metronidazole or pantoprazole
pregnant patients
chronic or severe disease
Age
From 18 years old to 80 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
The patients are randomly divided by using a computer-generated random number list. The subjects are assigned into different groups by random allocation. Allocation concealment is obtained by maintaining the randomization list by study statistician.
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 Babol University of Medical Sciences
Street address
Babol university of medical sciences, Ganjafrouz ave, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2018-09-16, 1397/06/25
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.182
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
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
Rate of H pylori eradication
Timepoint
six weeks after the end of treatment
Method of measurement
H. pylori stool antigen test
Secondary outcomes
1
Description
side effects
Timepoint
six weeks after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: (N=60) this group take Amoxicillin 1 gr twice a day Levofloxacin 500 mg daily Metronidazole 500 mg twice a day Pantoprazole twice a day all regimen continue for 5 day
Category
Treatment - Drugs
2
Description
Control group: (N=60) this group take Amoxicillin 1 gr twice a day Levofloxacin 500 mg daily Metronidazole 500 mg twice a day Pantoprazole twice a day all regimen continue for 10 day