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.: PACTR202304550587833 Date of Approval: 05/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison of bismuth quadruple therapy with Clarithromycin quadruple therapy in the treatment of Helicobacter pylori
Official scientific title Comparison of bismuth quadruple therapy with Clarithromycin quadruple therapy in the treatment of Helicobacter pylori: a randomized controlled trial
Brief summary describing the background and objectives of the trial Helicobacter Pylori infection is a public health problem due to its high prevalence (50% worldwide and 70% in Tunisia) and its association with ulcer disease and gastric adenocarcinoma and lymphoma. The indications for eradication of HP are increasingly broad, however we are faced with an emergence of resistance to major antibiotics. The two main therapeutic regimens used worldwide are a Clarithromycin-based quadritherapy (Amoxicillin + Clarithromycin + Metronidazole + PPI) and a Bismuth-based quadritherapy (Tetracycline + Metronidazole + Bismuth + PPI). These two protocols have a comparable safety profile. According to the Maastricht recommendations (2017), 1st line treatment is based on the rate of HP resistance to Clarithromycin. If this rate is greater than 15%, bismuth quadritherapy is indicated. A study conducted by the Tunisian Society of Gastroenterology in 2022 showed a rate of resistance to Clarithromycin and Metronidazole estimated at 27.9% and 42% respectively. Despite this rate of resistance, the rate of eradication of HP in PP was 88% with Clarithromycin-based quadritherapy. If the results of this study are confirmed, this quadruple therapy will continue to be prescribed because of its lower cost and availability. This study suffers from some methodological biases. It is a single-arm study that is not comparative and did not provide the intention-to-treat eradication rate. In our study, we propose to confirm these data while directly comparing Clarithromycin-based TQ with bismuth-based TQ in terms of efficacy, safety and cost.
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 01/03/2023
Actual trial start date
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Bis group Pylera 3 capsules 4 times a day Omeprazole 1 capsule twice a day 10 days Patients will receive treatment with pylera 3 capsules 4 times daily after meals with omeprazole 20 mg twice daily before meals for 10 days. After 6 weeks they will have an urea breath test to check the eradication. 100
Control Group Cla group Amoxicillin 1000 mg twice daily Metronidazole 500 mg twice daily Clarithromycin 500 mg twice daily Esomeprazole 40 mg twice daily 14 days Patients will receive Amoxicillin 1000 mg twice daily, Metronidazole 500 mg twice daily, Clarithromycin 500 mg twice daily, Esomeprazole 40 mg twice daily for 14 days. 6 weeks later they will have a urea breath test to check the eradication. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18 to 60 years. Patients with H. pylori infection documented by pathological evidence (gastric biopsy), by breath test or by H. pylori Antigen in stool and who have never received H. pylori eradication treatment. Patients who gave informed consent for participation in our research. Patient has serious underlying diseases such as hepatic failure, renal failure , immunosuppression, malignancies, coronary artery disease, or severe psychiatric or neurological disorders. The patient is a pregnant or lactating woman. Patient has active gastrointestinal bleeding or a history of upper gastrointestinal surgery. The patient is allergic to the drugs in the treatment. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 05/12/2022 patient safety committee
Ethics Committee Address
Street address City Postal code Country
Bab alioua Tunis 7000 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Compare the Helicobacter pylori eradication rate of the two tested regimens six weeks
Secondary Outcome Adverse event rates six weeks
Secondary Outcome Patient compliance: Good compliance is defined as the actual dose being within 80-100% of the dose that should be taken. six weeks
Secondary Outcome Cost-effectiveness index: Ratio of cost to effectiveness six weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Military hospital of Tunis Bab alioua Tunis 7000 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Military Hospital of Tunis Bab alioua Tunis 7000 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Galpharma Sfax Tunis 7000 Tunisia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Oueslati oueslatialaa1996@gmail.com +21621747760 Ben Arous
City Postal code Country Position/Affiliation
Boumhal 2097 Tunisia Resident
Role Name Email Phone Street address
Scientific Enquiries Ghanem Mohamed med.ghanem@yahoo.fr +21620011015 tunis
City Postal code Country Position/Affiliation
tunis Tunisia professor
Role Name Email Phone Street address
Public Enquiries Sonia Bostani soniaboss@gmail.com +21623736300 manouba
City Postal code Country Position/Affiliation
tunis Tunisia resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual deidentified participant data (including data dictionaries) will be shared with all of the individual participant data collected during the trial after deidentifcation Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately following publication Data will be available with anyone who wishes to access the data
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