Comparison of Two Treatment Regimens of Helicobacter Pylori Infection

Rehman Medical Institute - RMI

Status and phase: Not yet enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Levofloxacin; Drug: Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT07021729

RMI/RMI-REC/approval/181

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 12 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Regime 1

Active Comparator group

Description:

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

Treatment:

Drug: Clarithromycin

Regime 2

Active Comparator group

Description:

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

Treatment:

Drug: Levofloxacin