Protocol summary

Study aim
Comparison of the efficacy of Levofloxacin and Clarithromycin in quadruple therapy for the eradication of Helicobacter pylori
Design
In this study, 210 patients with peptic ulcer and proven Helicobacter pylori infection referred to the Alzahra Gastrointestinal Hospital will be included in the study and will be randomly assigned to two groups of intervention and control and each participant will be assigned a code.
Settings and conduct
This study is a randomized clinical trial. Adults with peptic ulcer and proven Helicobacter pylori infection referred to the Alzahra Gastrointestinal Hospital will be included in the study and will be randomly assigned to two groups. The first group is treated with Clarithromycin 500 mg twice daily, Amoxicillin 1 g twice daily, Bismuth 525 mg twice daily, and Pentazole 40 mg twice daily for two weeks. The second group of patients will take levofloxacin 500 mg daily for two weeks instead of clarithromycin. To determine the success of eradication, a stool antigen test will be used at least 4 weeks after the end of the treatment. To assess the severity of symptoms, a short form of the Leeds Dyspepsia Questionnaire at the beginning of the study and the eradication evaluation (4 weeks after the completion of the treatment) will be completed through the interview. To measure the side effects, a standard questionnaire will be completed at the end of the course (day 15) and then at the time of the eradication evaluation (4 weeks after treatment) through the interview. Patient tolerance is measured with five good options, mild intolerance, moderate intolerance, severe intolerance, and forced discontinuation of medication through an interview at the end of the treatment period (day 15). Finally, data analysis is done through SPSS v.16 and Chi-Square, Independent Sample T-Test and MC Nemar tests in both Intention to Treat and Per-Protocol methods.
Participants/Inclusion and exclusion criteria
People over 18 years of age with Helicobacter pylori infection proven without previous history of severe illness, surgery and previous Helicobacter pylori infection
Intervention groups
The control group consisted of patients treated with Clarithromycin based on four regimens and the intervention group included patients treated with four drugs based on levofloxacin.
Main outcome variables
Eradication of Helicobacter Pylori infection Separated drug effects Dyspepsia severity Patient tolerance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171223038001N1
Registration date: 2018-01-05, 1396/10/15
Registration timing: registered_while_recruiting

Last update: 2018-01-05, 1396/10/15
Update count: 0
Registration date
2018-01-05, 1396/10/15
Registrant information
Name
Reyhane Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3230 4933
Email address
reyhane_001@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-26, 1396/10/05
Expected recruitment end date
2018-12-26, 1397/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Levofloxacin and Clarithromycin in quadruple therapy for the eradication of Helicobacter pylori
Public title
Eraddication of Helicobacter pylori for quadruple therapy with base of Clarithromycin compared with Levofloxacin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 18 years and older Patients with dyspepsia and upper digestive tract symptoms Peptic Ulcers in Upper Gastrointestinal Endoscopy Helicobacter pylori infection in rapid test of urease The desire to participate in the study Lack of severe illness Not having a history of upper gastrointestinal surgery Not taking antibiotics, PPIs and NSAIDs in the last three months Not having eradication history of Helicobacter pylori Absence of ContraIndications for the Consumption of quadruple therapy
Exclusion criteria:
Low drug intake (for any reason) Incidence of severe drug complications during the study
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 210
Actual sample size reached: 133
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is consecutive. Patients who referred to the gastroenterologist for upper gastrointestinal symptoms and who have had ulcerative peptic ulcer endoscopy and who have been diagnosed with Helicobacter Pylori infection according to a quick test of urease, according to other criteria for entry and absence of study Then, after explaining how the plan is implemented and receiving written consent, patients are randomly assigned (using a random number table generated by Random Allocation Software) into two groups.
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 Isfahan University of Medical Sciences
Street address
Jey Ave, opposite Sarvestan, Haft Tir Alley, Afshin deadlock, 56 No
City
Isfahan
Province
Isfehan
Postal code
8156884541
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
ir.mui.rec.1396.3.010

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylor

Primary outcomes

1

Description
Eradication of Helicobacter pylori infection
Timepoint
Stool antigen Helicobacter pylori test 4 weeks after discontinuation of treatment
Method of measurement
Stool antigen Helicobacter pylori test

Secondary outcomes

1

Description
Dyspepsia severity
Timepoint
Before treatment and 4 weeks after treatment
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: Patients with Helicobacter Pylori infection receiving four regimens based on levofloxacin 500 mg once daily for 14 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital Gastrointestinal clinic
Full name of responsible person
reyhane hosseini
Street address
Jey Ave, opposite Sarvestan, Haft Tir Alley, Afshin deadlock, 56 No
City
Isfahan
Province
Isfehan
Postal code
8156884541
Phone
+98 31 3230 4933
Email
reyhane_001@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
vahid sebghatollahi
Street address
Sofah Blvd, Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8156884541
Phone
+98 31 3230 4933
Email
sebghatollahi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
reyhane hosseini
Position
Internal resident of medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Jey Ave, opposite Sarvestan, Haft Tir Alley, Afshin deadlock, 56 No
City
Isfahan
Province
Isfehan
Postal code
8156884541
Phone
+98 31 3230 4933
Email
reyhane_001@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
وحید سبقت اللهی
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Al-Zahra Hospital, Sofah Blvd
City
Isfahan
Province
Isfehan
Postal code
8156884541
Phone
+98 32304933
Email
sebghatollahi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
reyhane hosseini
Position
Internal resident of medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Jey Ave, opposite Sarvestan, Haft Tir Alley, Afshin deadlock, 56 No
City
Isfahan
Province
Isfehan
Postal code
8156884541
Phone
+98 31 3230 4933
Email
reyhane_001@yahoo.com

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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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