Comparison of Two Treatment Regimens of Helicobacter Pylori Infection

NCT07021729 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: RMI/RMI-REC/approval/181
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Helicobacter Pylori Infection

Keywords

clarithromycin; levofloxacin; helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• Treatment of H pylori infection

  Treatment of H pylori infection documented by negative stool antigen

  2weeks after completion of treatment regimen

Study Arms (2)

Regime 1

ACTIVE COMPARATOR

This arm will receive clarithromycin based regimen for eradication of H pylori infection (as per approved guidelines)

Drug: Clarithromycin

Regime 2

ACTIVE COMPARATOR

This arm will receive levofloxacin based regimen for eradication of H pylori infection (as per approved guidelines)

Drug: Levofloxacin

Interventions

Clarithromycin DRUG

Drug regimens will be given for 14 days, and omeprazole for 6weeks

Also known as: Metronidazole, omeprazole

Regime 1

Levofloxacin DRUG

Drug regimens will be given for 14 days, and omeprazole for 6weeks

Also known as: amoxicillin, omeprazole

Regime 2

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rehman Medical Institute - RMI: lead

Related Publications (8)

• 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 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.

  PMID: 26187502 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.

  PMID: 35668511 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.

  PMID: 27707777 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.

  PMID: 25038206 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.

  PMID: 27999644 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.

  PMID: 29657940 BACKGROUND

MeSH Terms

Interventions

Clarithromycin; Metronidazole; Omeprazole; Levofloxacin; Amoxicillin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Wajeeha Qayyum, FCPS

  Rehman Medical Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wajeeha Qayyum, FCPS

CONTACT

092915838000; wajeeha.qayyum@rmi.edu.pk

Taimur Khan, FCPS

CONTACT

092915838000; taimur.khan@rmi.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant/Assistant Professor Medicine

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: June 15, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL