A Phase 4 interventional study of Clarithromycin and Levofloxacin in Helicobacter Pylori Infection, sponsored by Rehman Medical Institute - RMI. Not yet recruiting. Open to participants aged 12 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by Rehman Medical Institute - RMI · Phase 4, Interventional, and Treatment
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:
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.
Exclusion Criteria:
This arm will receive clarithromycin based regimen for eradication of H pylori infection (as per approved guidelines)
Drug: Clarithromycin
This arm will receive levofloxacin based regimen for eradication of H pylori infection (as per approved guidelines)
Drug: Levofloxacin
Drug regimens will be given for 14 days, and omeprazole for 6weeks
Also known as: Metronidazole, omeprazole
Drug regimens will be given for 14 days, and omeprazole for 6weeks
Also known as: amoxicillin, omeprazole
Treatment of H pylori infection
Treatment of H pylori infection documented by negative stool antigen
Time frame: 2weeks after completion of treatment regimen
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Rehman Medical Institute - RMI