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.: PACTR202208494077478 Date of Approval: 24/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Antibiotic Resistance in Helicobacter Pylori: Genetic Bases and Clinical Outcomes
Official scientific title Antibiotic Resistance in Helicobacter Pylori: Genetic Bases and Clinical Outcomes
Brief summary describing the background and objectives of the trial H. pylori infection is considered as one of the most frequent bacterial infections of the digestive system in the world (Peretz et al., 2014). There are strong data showing that eradication of H. pylori infection reduces the risk of peptic ulcers, dyspepsia, and likely gastric cancer, if treated early in its natural history. H. pylori management in the clinical practice remains a challenge for the physicians. The choice of appropriate antibiotics is crucial in the success of treatment and recovery from H. pylori-related diseases (Stollman, 2016). H pylori eradication failure is due to a pre-existing antimicrobial resistant H. pylori strain or emergence of a new resistant strain from a susceptible ancestor. The successful eradication attempts are inversely correlated with antimicrobial resistance rates (Selgrad, 2013; Graham & Shiotani, 2008 and Boyanova & Mitov, 2010). Information on resistance rates is not widely available to clinicians. As antibiotic resistance is a constantly evolving process and there is significant variation in resistance rates between countries and within different regions of the same country, so it is important that local surveillance of primary antibiotic resistance is performed. The guidelines recommend abandoning the standard triple therapy when the primary clarithromycin resistance rate is over 20% (Malfertheiner et al., 2011). Data about H.pylori antibiotic resistance is scarce in Egypt. H.pylori genetic mutation A2142G within the H. pylori 23S rRNA V domain (responsible for Clarithromycin resistance) was evidenced in 55.7% of Egypt. The aim of this work is to assess: 1) The prevalence of H.pylori antibiotic resistance (for commonly used antibiotics in H. pylori treatment) by culture and sensitivity. 2) The prevalence of H.pylori clarithromycin genetic resistance (by genetic mutations A2142G and A2143G within the H. pylori 23S rRNA V domain). 3) Effect of presence of antibiotic resistance on outcome of treatment.
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 24/11/2020
Actual trial start date 15/12/2020
Anticipated date of last follow up 31/08/2021
Actual Last follow-up date 24/11/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
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 Permuted block randomization 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 500 mg once daily 14 days Levofloxacin oral tablet (500 mg), given once daily for 14 days plus Esomeprazol oral tab 40 mg twice daily , 30 minutes before meal and Amoxicillin oral caps 1000 mg twice daily 50
Control Group Clarithromycin Clarithromycin oral tablet 500 mg Twice daily 14 days Clarithromycin oral tablet (500 mg), given twice daily for 14 days plus Esomeprazol oral tab 40 mg twice daily , 30 minutes before meal and Amoxicillin oral caps 1000 mg twice daily 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
 All adult patients who are indicated for upper endoscopy.  Age less than 18 years old.  Previous H. pylori treatment.  Consumption of antibiotics or bismuth salts in the previous four weeks.  Consumption of antisecretory drugs or sucralfate in the previous two weeks.  A history of bleeding or a coagulation disorder that contraindicates biopsy sampling. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 04/11/2020 Benha University Faculty of Medicine Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Farid Nada Street Benha 31518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Eradication of H pylori defined as H pylori stool antigen negative by ELISA test 4 weeks after completing treatment.
Secondary Outcome Eradication rate in H pyori with genetic resistant clarithromycin 4 weeks after stopping treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha University Farid Nada St. Benha 31518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Principle investigator Farid Nada street Benha Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed A. Metwally Benha University Farid Nada St. Benha 31518 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Sayed NHTMRI Kasr Alainy street Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Metwally mohamed.metwally@fmed.bu.edu.eg 00201064917959 Farid Nada St
City Postal code Country Position/Affiliation
Benha 31518 Egypt Hepatology Gastroenterology and Infectious Diseases Department Benha University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Sayed msayed@gmail.com 00201022324011 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt National Hepatology and Tropical Medicine Research nstitute
Role Name Email Phone Street address
Public Enquiries Samir Fathy Samerfathi2012@gmail.com 00201065264003 Farid Nada St.
City Postal code Country Position/Affiliation
Benha Egypt Benha university hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I am ready to share IPD after approval of my institution within 12 months of completing the trial Clinical Study Report,Study Protocol within 12 months of comleting the study on demand from contact email of principle investigator
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