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Efficacy of Amoxicillin-Esomeprazole HDDT Compared to Levofloxacin Triple Therapy for H. Pylori Eradication: A RCT

NCT06088316 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-10-18

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the efficacy of two different therapeutic regimen for the treatment of Helicobacter pylori infected dyspeptic patients. The aim is -

1. To identify the percentage of H. pylori infection among dyspeptic patients
2. To compare the efficacy of amoxicillin-esomeprazole high dose dual therapy with levofloxacin containing triple therapy for the eradication of Helicobacter pylori.

Participants will be screened on the basis of two different test (stool antigen test \& endoscopy with rapid urease test) to detect H. pylori infection. Who are positive on both tests will be finally enrolled in the study and randomized into two groups . one group will receive amoxicillin \& esomeprazole for 14 days in higher dose. The other group will receive amoxicillin, levofloxacin \& esomeprazole for 14 days in usual dose.

Dyspeptic symptoms will be recorded before \& after treatment. Side effects of drugs will also be recorded. Finally 1 month after completion of treatment , H.pylori status will be cheeked by stool antigen test and results will be compared between two groups.

Conditions

  • Helicobacter Pylori Infection
  • Helicobacter Pylori Eradication

Interventions

DRUG

group A : Amoxicillin Esomeprazole HDDT

Group A - Amoxicillin 1gm 8 hourly after meal \& esomeprazole 40mg 8 hourly 30 minutes before meal for 14 days. Group-B - Levofloxacin 500mg once daily after meal, Amoxicillin 1gm 12 hourly after meal \& Esomeprazole 20mg 12 hourly 30 minutes before meal for 14 days.

DRUG

group-B : Levofloxacin triple therapy

Group-B - Levofloxacin 500mg once daily after meal, Amoxicillin 1gm 12 hourly after meal \& Esomeprazole 20mg 12 hourly 30 minutes before meal for 14 days.

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Salman Rafat, Mbbs · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2024-02-29
Completion
2024-02-29

Countries

  • Bangladesh

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 NCT06088316 on ClinicalTrials.gov