Clinical trial NCT07021729: Comparison of Two Treatment Regimens of Helicobacter Pylori Infection
Official title: Comparison of Conventional Clarithromycin Vs Alternative Levofloxacin Based Regimen in Treatment of Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: clarithromycin
levofloxacin
helicobacter pylori
Lead sponsor: Rehman Medical Institute - RMI
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 156
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* All patients who tested positive on stool antigen 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.

Primary outcomes:
measure: Treatment of H pylori infection
timeFrame: 2weeks after completion of treatment regimen
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rehman Medical Institute
name: Wajeeha Qayyum, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.