Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202012742050337 Date of Approval: 07/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between clarithromycin and levofloxacin in treatment of H pylori
Official scientific title Levofloxacin-based versus Clarithromycin-based triple therapy for Treatment of Helicobacter pylori
Brief summary describing the background and objectives of the trial Background: Helicobacter pylori (H.pylori) plays a crucial role in the pathogenesis of gastritis, non-ulcer dyspepsia, peptic ulcer diseases and gastric cancer ( Fuccio etal.,2009). Eradication of H pylori can lead to reduction in the recurrence of peptic ulcer diseases and prevention of gastric cancer, and has been recommended in several consensus conferences (Talleyetal.,2008) . One of the most commonly used first-line regimens is clarithromycin-based triple therapy for 7-14 days ( Chey & Wong , 2007 ) . With the increasing prevalence of antibiotic resistance to clarithromycin, the eradication rate with standard first-line treatment has fallen to <80% in many countries (Graham &Shiotani , 2006 ) . Therefore, several alternative first-line regimens, including levofloxacin-based treatment and sequential treatment, have been proposed . Levofloxacin-based triple therapy have been shown to be effective as the second-line and third-line rescue regimens for those who failed standard treatment, with an eradication rate ranging from 75 to 90% ( Lee et al., 2006). Recent studies have also shown that levofloxacin-based triple therapy is as effective as the first-line treatment. Nista et al,2006 reported that triple therapy comprising levofloxacin, clarithromycin and esomeprazole for 7 days achieved a higher eradication rate (87%) than clarithromycin-based triple therapy comprising clarithromycin, esomeprazole and either amoxicillin (75%) or metronidazole (72%) ( Nista et al.,2006 ) . However, validation of the efficacy of levofloxacin-based treatment as the first-line treatment is required before its clinical application in different countries. Aim: To evaluate two regimens of therapy for H pylori namely ( Levofloxacin, amoxicillin and esomeprazol ) and (Clarithromycin, amoxicillin and esomeprazol) regarding the safety and efficacy as a first line treatment of H.pylori .
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Helicobacter pylori
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/12/2020
Actual trial start date
Anticipated date of last follow up 15/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Levofloxacin plus amoxycillin plus esomeprazol 500 mg levofloxacin once daily plus 1 gm amoxycillin BID plus 40 mg Esomeprazole BID 14 days Drug in the form of oral tablets and capsule 100
Control Group Clarithromycine plus Amoxicillin plus Esomeprazol Clarithromycine 500 mg BID plus Amoxicillin 1 gm BID plus Esomeprazol 40 mg BID 14 days Oral tablets and capsule 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age group: ≥ 18 year. Treatment-naiive patients. Positive H pylori stool antigen or histopathology. Previous experience of treatment of H pylori. Known allergy to any of the medication used 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/03/2019 Benha Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Farid Nada St Benha 31518 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/12/2020 Benha Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Farid Nada St Benha 31518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cure confirmed by negative H pylori stool antigen 4 weeks after stopping treatment
Secondary Outcome Safety by measuring side effects 14 days of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patient clinic and inpatient ward of Hepatology Gastroenterology and Infectious Diseases department Benha University Hospital Farid Nada St Benha 31518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha Univerisity Farid Nada St. Benha Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha University Hospital Farid Nada St. Benha Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Metwally mohamed.metwally@fmed.bu.edu.eg 00201064917959 Hepatology and Gastroenterology Dept, Benha University Hospital, Farid Nada St
City Postal code Country Position/Affiliation
Benha Egypt Professor Hepatology Gastroenterology and Infectious Diseases
Role Name Email Phone Street address
Public Enquiries Samer Fathy samerfathi2012@gmail.com 00201065264003 Hepatology and Gastroenterology Dept, Benha University Hospital, Farid Nada St
City Postal code Country Position/Affiliation
Benha Egypt Department Secretary
Role Name Email Phone Street address
Scientific Enquiries Mohamed Balabel mhmdmosad89@gmail.com 00201069585245 Hepatology and Gastroenterology Dept, Benha University Hospital, Farid Nada St
City Postal code Country Position/Affiliation
Benha Egypt Doctor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes These data are available on request from principle investigator through email contact Statistical Analysis Plan,Study Protocol for 6 months after getting the results Available on request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information