drugset / Trial / NCT07021729
Comparison of Two Treatment Regimens of Helicobacter Pylori Infection
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2025-12
- Primary completion
- 2026-03
- Completion
- 2026-06
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 1 g | — |
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Comparator | Levofloxacin | Small molecule | 500 mg | — |
| Comparator | Metronidazole | Small molecule | 400 mg | — |
| Comparator | Omeprazole | Other / unclassified | 40 mg | — |