Comparison of Two Treatment Regimens of Helicobacter Pylori Infection

Официальное название

Comparison of Conventional Clarithromycin Vs Alternative Levofloxacin Based Regimen in Treatment of Helicobacter Pylori Infection

Обзор

The goal of this interventional study is to compare the efficacy of clarithromycin Vs levofloxacin based regimen in treatment of Helicobacter pylori infection in patients presenting to medical OPD who are tested positive for H pylori infection.. The main question\[s\] it aims to answer are: • Which regimen is superior in terms of efficacy Participants will be treated for H pylori Infection in with two different regimen If there is a comparison group: Researchers will compare two groups Group 1 will receive clarithromycin based regimen group 2 will receive levofloxacin based regimen to see the treatment response.

Подробное описание

This interventional study will be conducted in department of medicine, Rehman Medical Institute, Peshawar.

Study duration: 10 months after the issuance of ethical approval Sample size: Sample size is calculated using a two-tailed alpha test with a significance level of 0.05 and 90% power to detect 23% difference in the eradication rate of the two regimens. The total number of patients required to prove the hypothesis is 156, 78 in each group.

Study population: Patients coming to OPD with symptoms suggestive of H pylori infection will undergo screening by Hpylori stool antigen. If it comes to be positive then they will be enrolled in study after applying inclusion/exclusion criteria.

Inclusion criteria: All patients who tested positive on stool antigen will be included. Age \>12 years and both genders will be included.

Exclusion criteria: patients under 12 years old. Patients who have penicillin allergy.

Patients who have underlying dysrhythmia forbidding the use of macrolide. Patient who have hypersensitivity to any of these antibiotics.

Study population will be divided in two groups. Group 1 will receive regimen number 1 and group 2 will receive regimen number 2.( regimens are described below.) Regimen 1 (R1): Clarithromycin 500mg BD, plus metronidazole 400mg TDS for 14days and Omeprazole 40mg BD for 6 weeks.

Regimen 2(R2): Levofloxacin 500mg OD plus Amoxicillin 1gm BD for 14 days and omeprazole 40mg Bd for 6 weeks.

The patients will be followed 2 weeks after completion of treatment. On follow up, their symptoms improvement, compliance and side effects will be documented. They will undergo stool Ag test again to assess treatment response.

Вмешательства

• Препарат Clarithromycin
  Drug regimens will be given for 14 days, and omeprazole for 6weeks
• Препарат Levofloxacin
  Drug regimens will be given for 14 days, and omeprazole for 6weeks

Первичные конечные точки

• Treatment of H pylori infection [Срок оценки: 2weeks after completion of treatment regimen]

Критерии участия

Критерии включения

• All patients who tested positive on stool antigen will be included.

Критерии исключения

• patients under 12 years old. Patients who have penicillin allergy.
• Patients who have underlying dysrhythmia forbidding the use of macrolide.
• Patient who have hypersensitivity to any of these antibiotics.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Hooi JKY, Lai WY, Ng WK, Suen MMY, Underwood FE, Tanyingoh D, Malfertheiner P, Graham DY, Wong VWS, Wu JCY, Chan FKL, Sung JJY, Kaplan GG, Ng SC. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017 Aug;153(2):420-429. doi: 10.1053/j.gastro.2017.04.022. Epub 2017 Apr 27. PMID 28456631
• Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17. PMID 26187502
• 4. Shah SRH, , Almugadam BS, Hussain Akbar, Ahmad T, Ahmed S , Sadiqui S. Epidemiology and risk factors of Helicobacter pylori infection in Timergara city of Pakistan: A cross-sectional study. Clinical Epidemiology and Global Health 12 (2021) 100909.
• Azab ET, Thabit AK, McKee S, Al-Qiraiqiri A. Levofloxacin versus clarithromycin for Helicobacter pylori eradication: are 14 day regimens better than 10 day regimens? Gut Pathog. 2022 Jun 6;14(1):24. doi: 10.1186/s13099-022-00502-3. PMID 35668511
• Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.11 PMID 27707777
• Rizwan M, Fatima N, Alvi A. Epidemiology and pattern of antibiotic resistance in Helicobacter pylori: scenario from Saudi Arabia. Saudi J Gastroenterol. 2014 Jul-Aug;20(4):212-8. doi: 10.4103/1319-3767.136935. PMID 25038206
• Haji-Aghamohammadi AA, Bastani A, Miroliaee A, Oveisi S, Safarnezhad S. Comparison of levofloxacin versus clarithromycin efficacy in the eradication of Helicobacter pylori infection. Caspian J Intern Med. 2016 Fall;7(4):267-271. PMID 27999644
• Sebghatollahi V, Soheilipour M, Khodadoostan M, Shavakhi A, Shavakhi A. Levofloxacin-containing versus Clarithromycin-containing Therapy for Helicobacter pylori Eradication: A Prospective Randomized Controlled Clinical Trial. Adv Biomed Res. 2018 Mar 27;7:55. doi: 10.4103/abr.abr_133_17. eCollection 2018. PMID 29657940

Идентификаторы

NCT: NCT07021729 · RMI/RMI-REC/approval/181

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗