This study aimed to compare a triple therapy regimen based on change of antibiotic (Azithromycin and Clarithromycin) for the eradication of helicobacter pylori in patients with end stage renal disease under treatment of hemodialysis. In this prospective, randomized, double-blinded trial, thirty nine dialysis patients, aged 17–88 years old, referred to two hemodialysis centers (Valiasr & Beheshti hospitals) in Zanjan were enrolled between March to October 2008. The patients were randomly assigned into one of two groups. The first Group received Omeprazol 20 mg, Amoxycilin 500 mg, and Clarithromycin 500mg twice a day, while the second group received Omeprazol 20mg, Amoxicillin 500mg, and Azithromycin 250mg twice a day for 14 days. The adverse events and compliance with triple therapy were reviewed weekly. Eradication of infection was assessed using UBT and HpSAg eight weeks after therapeutic regimens.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811223325N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Majgan Jalalzadeh
Name of organization / entity
Zanjan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 1426 6934
Email address
jmojgan@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2008-10-22, 1387/08/01
Expected recruitment end date
2009-02-19, 1387/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Azithromycin and Clarithromycin in triple therapy regimens for eradication of helicobacter pylori in hemodialysis patients
Public title
H. Pylori In Hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of dyspepsia, positive results of H. pylori infection in two out of three diagnostic tests: anti H. pylori serology, H.pylori stool antigen (HpSAg) and Urease Breath Test (UBT)
Exclusion criteria: history of previous treatment for H. Pylori, use of any of the investigated antibiotics in the previous six months, allergy to study medications, inability to perform UBT
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Zanjan
City
Zanjan
Postal code
Approval date
2010-02-23, 1388/12/04
Ethics committee reference number
19/3-304488
Health conditions studied
1
Description of health condition studied
helicobacter pylori
ICD-10 code
B96.8
ICD-10 code description
Other specified bacterial agents as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Adverse evente and compliance
Timepoint
one visit a week
Method of measurement
Questionnarie
Secondary outcomes
1
Description
H pylori eradication
Timepoint
Eight weeks after therepeutic regimen
Method of measurement
UBT
Intervention groups
1
Description
Omeprazol 20 mg, Amoxycilin 500 mg, and Clarithromycin 500mg twice a day, for 14 days
Category
Treatment - Drugs
2
Description
Omeprazol 20mg, Amoxicillin 500mg, and Azithromycin 250mg twice a day, for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis Center of Zanjan City - Iran
Full name of responsible person
Dr Mojgan Jalalzadeh
Street address
Valiasr Hospital of Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan Univercity Of Medical Science
Full name of responsible person
Mr Jafari Anaekoli
Street address
Zanjan, Azadi Square P.C. 45154-11447
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan Univercity Of Medical Science
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
Qom Univrecity of Medical Sciences
Full name of responsible person
Jamshid Vafaee Manesh
Position
Assistant Professor
Other areas of specialty/work
Street address
Qum Univrecity of Medical Sciences, Qom
City
Qom
Postal code
Phone
+98 25 1290 6135
Fax
Email
JVAFAEEMANESH @YAHOO.COM-j.vafaeemanesh@muq.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom Univercity of Medical Sciences
Full name of responsible person
Jamshod Vafaeemanesh md
Position
Assistant Professor
Other areas of specialty/work
Street address
Qom
City
Qom
Postal code
Phone
+98 25 1290 6135
Fax
Email
j.vafaeemanesh@muq.ac.irJVAFAEEMANESH @YAHOO.COM
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Jamshid Vafaee Manesh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
j.vafaeemanesh@muq.ac.irJVAFAEEMANESH @YAHOO.COM
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)