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Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt

NCT04039412 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-11-26

Study results available
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Summary

The overall prevalence of H. Pylori in the developing countries is 50.8%, with the highest one presented in Africa (79.1%). Hybrid therapy is supposed to be more effective as a first-line regimen for Helicobacter pylori infection in Egypt than the Reverse hybrid and non-bismuth Levofloxacin quadruple therapies. We are aiming here to compare the Hybrid, Reverse hybrid, and Levofloxacin quadruple therapies as first-line therapy, trying to reach the safest, cost-effective, and compliance-inducing regimen in Egypt. We will conduct a randomized controlled (interventional) study at Zagazig University Hospital, internal medicine department clinic, on 330 patients. 110 patients will be allocated to each regimen.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Hybrid regimen

two-step (dual-quadruple) treatment

DRUG

Reverse hybrid regimen

one-step two-phase (quadruple-dual) treatment

DRUG

Levofloxacin quadruple regimen

non-Clarithromycin non-Bismuth quadruple therapy

Sponsors & Collaborators

  • Ayman Magd Eldin Mohammad Sadek

    lead OTHER_GOV

Principal Investigators

  • Ayman MM Sadek, MD · Zagazig University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2018-12-22
Completion
2019-06-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04039412 on ClinicalTrials.gov