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Helicobacter Pylori InfectionPhase 4NCT07021729

Comparison of Two Treatment Regimens of Helicobacter Pylori Infection

A Phase 4 study testing Clarithromycin and Levofloxacin in people with Helicobacter Pylori Infection, run by Rehman Medical Institute - RMI.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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.. Read more about this study

Who is it for?
Ages 12 to 90 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Clarithromycin and Levofloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
No sites listed yet
Study dates
Dec 2025to Jun 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wajeeha Qayyum, FCPS contact

092915838000 ext. 3638

wajeeha.qayyum@rmi.edu.pk

Taimur Khan, FCPS contact

092915838000

taimur.khan@rmi.edu.pk

About this study

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

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.
Read the detailed description

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.

Being tested
Clarithromycin, Levofloxacin
Keywords
clarithromycin, levofloxacin, helicobacter pylori

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClarithromycinDrug

    Also called Metronidazole, omeprazole

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

  • LevofloxacinDrug

    Also called amoxicillin, omeprazole

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

Study groups in NCT07021729
Study groupRoleWhat they receive
Regime 1Active comparatorThis arm will receive clarithromycin based regimen for eradication of H pylori infection (as per approved guidelines)
Receives: Drug: Clarithromycin
Regime 2Active comparatorThis arm will receive levofloxacin based regimen for eradication of H pylori infection (as per approved guidelines)
Receives: Drug: Levofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment of H pylori infection

    Treatment of H pylori infection documented by negative stool antigen

    Measured: 2weeks after completion of treatment regimen

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021729
Sponsor's protocol ID
RMI/RMI-REC/approval/181
Status last verified
Jun 2025
First submitted
17 Aug 2023
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29657940

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clarithromycin and Levofloxacin in people with Helicobacter Pylori Infection, run by Rehman Medical Institute - RMI.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wajeeha Qayyum, FCPS (092915838000 ext. 3638, wajeeha.qayyum@rmi.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment of H pylori infection (time frame: 2weeks after completion of treatment regimen). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07021729, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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