Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era

Efficacy of Clarithromycin and Flouroquinolones Based Regimens in H.Pylori Eradication in Covid-19 Era: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05035186

Enrollment

233

Registered

2021-09-05

Start date

2021-03-21

Completion date

2021-11-30

Last updated

2022-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief 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.

Interventions

DRUGAmoxicillin

Anti-H. pylori regimens

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* • Patients aged 18-65 years old with newly diagnosed positive H. pylori antigen in stools, urea breath test or H. pylori detected on endoscopy.

Exclusion criteria

* • Women who are pregnant or lactating, patients previously treated with H. pylori eradication therapy, those with recent exposure to antibiotics within the previous 3 months, patients who previously underwent gastric surgery, patients with malignant neoplasms, and patients with other severe concomitant diseases like renal, hepatic impairement, heart failure NYHA class II or more, hypoalbuminemia and those with possible clinically significant drug-drug interaction with any of the study's drugs will be excluded. * Known allergy to antibiotics.

Design outcomes

Primary

Measure	Time frame
H. pylori eradication rates	6 weeks from end of treatment and at least 2 weeks with no administration of PPIs

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026