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IRCT20200707048038N1 IRCT 2020-11-24 Ahvaz University of Medical Sciences Comparison of the efficacy of a levofloxacin-tetracycline-based quadriple regimen with a clarithromycin-based regimen to eradicate Helicobacter pylori infection Comparison of the efficacy of a levofloxacin-tetracycline-based quadriple regimen with a clarithromycin-based regimen to eradicate Helicobacter pylori infection 2020-08-22 anticipated 192 Complete https://irct.ir/trial/49497 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The diagnosis is based on endoscopic biopsy and rapid urease test (RUT) and is performed by the therapist. After selecting the patients, a written consent form is given to the patients and while explaining about the common side effects and results of taking the drugs, the patient enters the study. The patient can be excluded from the study at any time, depending on his choice. The cost of drugs is provided by the researcher, the drugs are from one brand and will be delivered to the patient. Common side effects leading to discontinuation of the patient or dangerous side effects that require medication should not be continued (for example, nausea and gastrointestinal upset with antibiotics are common, and dangerous side effects such as hypersensitivity reactions, tendonitis). Therefore, in case of leaving the study due to drug side effects, it will be mentioned in the study results. At the end of the fourth week after the treatment, the eradication is confirmed by a stool antigen test, and we will prove the effectiveness of the bacterial eradication treatment. Assessing the patient's acceptance in relation to the correct and complete use of drugs by the therapist and by observing the amount of remaining drugs and asking the patient directly every two weeks by phone and asking about the side effects of drugs, continuing treatment and creating the necessary knowledge about the importance of completing treatment will be done. If the patient takes the full course of fourteen days of antibiotic treatment, it will be considered as a complement to the treatment. All data will be completed in a questionnaire by the therapist (attached at the bottom of the questionnaire), Randomization description: These people are based on the method of simple randomization of numbers before starting the study with Random allocation software. No concealment is done for the reader and patients will be assigned to group A or B based on random numbers upon entry. 3 H pylori infection. Intervention 1: Intervention group: four-agents-based on levofloxacin-tetracycline-group A.Tetracycline-levofloxacin group regimen includes: tetracycline 500 mg every 12 hours, levofloxacin 500 mg daily, bismuth subcitrate 240 mg every 12 hours and pentaprazole 40 mg every 12 hours for 14 days and then pentaprazole at a dose of 40 mg every 12 hours It lasts for four weeks. Intervention 2: Control group: clarithromycin-based-group B, quadruple -agents.. Clarithromycin-amoxicillin regimen includes: clarithromycin 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours, bismuth subcitrate 240 mg every 12 hours, and pentaprazole 40 mg every 12 hours for 14 days, followed by pentaprazole at a dose of 40 mg. Mg every twelve hours for four weeks. Yes - There is a plan to make this available What will be shared: The data is entered in an Excel file and is with the reader, and if other researchers wish, it can be accessed by email after submitting the final article. When: One year after the publication of the article To whom: Researchers working in academic and scientific institutions Conditions: For meta-analysis studies only, citing the source Where to obtain: Contact the researcher email pezhmanalavinejad@gmail.com How to obtain: Contact the researcher email pezhmanalavinejad@gmail.com Comments:
public Tahmineh Farbod Ara
Ahwaz. Azadegan St. - Imam Khomeini Educational and Medical Center
Ahvaz Iran (Islamic Republic of) 00986193673166 0098612222922 tfarbodara@gmail.com Ahvaz University of Medical Sciences scientific Tahmineh Farbod Ara
Azadegan St. - Imam Khomeini Medical Center of Ahvaz
Ahvaz Iran (Islamic Republic of) 00986193673166 +98 61 3222 2922 tfarbodara@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) selection of patients based on clinical complaint of non-ulcer dyspepsia and endoscopy (confirmation of peptic ulcer or pathological confirmation of intestinal metaplasia or gastritis in the field of H. pylori) with a positive RUT test no previous treatment for H. pylori infection no use of quinolone and macrolide antibiotics during the last two months. over 18 years of age. 18 years no limit Both Severe side effects of the drug that lead to discontinuation of the drug before completing one week of treatment B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: four-agents-based on levofloxacin-tetracycline-group A.Tetracycline-levofloxacin group regimen includes: tetracycline 500 mg every 12 hours, levofloxacin 500 mg daily, bismuth subcitrate 240 mg every 12 hours and pentaprazole 40 mg every 12 hours for 14 days and then pentaprazole at a dose of 40 mg every 12 hours It lasts for four weeks. Control group: clarithromycin-based-group B, quadruple -agents.. Clarithromycin-amoxicillin regimen includes: clarithromycin 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours, bismuth subcitrate 240 mg every 12 hours, and pentaprazole 40 mg every 12 hours for 14 days, followed by pentaprazole at a dose of 40 mg. Mg every twelve hours for four weeks. Percentage of people with non-ulcer dyspepsia. Timepoint: at initiation of study. Method of measurement: performing upper gastrointestinal endoscopy. Percentage of people with intestinal metaplasia. Timepoint: at initiation of study. Method of measurement: performing upper gastrointestinal endoscopy. Percentage of people with peptic ulcer disease. Timepoint: at initiation of study. Method of measurement: performing upper gastrointestinal endoscopy. H-pylori eradication. Timepoint: after completing treatment. Method of measurement: Stool antigen test for H-pylori. Drug side effect. Timepoint: every week. Method of measurement: according to patient. Ahvaz University of Medical Sciences Approved 2020-11-21 Ethics Committee of Golestan Educational and Medical Center, Ahvaz Khuzestan Province, Ahvaz Golestan - Farvardin St. - Golestan Educational and Medical Center Ahvaz Khouzestan Iran (Islamic Republic of)