Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era
Status:
Recruiting
Trial end date:
2021-11-21
Target enrollment:
Participant gender:
Summary
Era of COVID-19 and the related panic lead to widely spread antibiotics misuse especially for
azithromycin. Cross sensitivity between azithromycin and clarithromycin can impact success
rates of H. pylori treatment regimens.(1) Here we aim to explore this point in Egyptian
patients.
Sample size Supposing the cure rate of clarithromycin-based regimen to levofloxacin based
regimen is 69% versus 84.5% respectively. Using Medcalc, the minimal required sample size is
116 patients for each arm (type 1 error= 5%, type II error=20%). Each arm increased by 10% to
compensate for drop-out. The sample size will be 135 for each arm.
Study Arms:
- Arm 1: The first group will receive (amoxicillin 1g/12 hrs, Clarithromycin 500 mg/12hrs,
esomeprazole 40mg/12hrs)
- Arm 2: The second group will receive (esomeprazole 40 mg/12hrs, levofloxacin 500 mg/24
hrs, and amoxicillin 1gm/12 hrs).
- To confirm patient compliance, we will ask patients to bring their remaining medication
and counted the rest of their pills. Patients with a compliance of <80% will be excluded
from the study per protocol (PP) analysis.