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

NCT06088316 | Unknown Phase 4

• 1 other identifier: 4270
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Helicobacter Pylori Infection; Helicobacter Pylori Eradication

Keywords

Helicobacter pylori; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy of amoxicillin-esomeprazole HDDT therapy with levofloxacin triple therapy for the eradication of Helicobacter pylori

  Group A will receive amoxicillin-esomeprazole high dose dual therapy for 14 days. Group-B patients will receive levofloxacin containing triple therapy 14 days. 1 month after completion of therapy, fresh stool sample will be collected from all patients for repeat stool antigen test \& H. pylori eradication will be recorded for each group. Eradication rate will be compared between two groups.

  1 month after completion of eradication therapy

Secondary Outcomes (1)

• Helicobacter pylori prevalence among dyspeptic patients

  stool antigen test & rapid urease test will be done 14 days after stopping PPI ,H2 receptor antagonist,bismuth preparation

Other Outcomes (2)

• dyspeptic symptoms improvement in group A & group B

  1 month

• Endoscopic mucosal healing in group-A & group-B

  1 month

Study Arms (2)

Group-A

EXPERIMENTAL

Group A will receive amoxicillin-esomeprazole high dose dual therapy that is amoxicillin 1gm 8 hourly after meal \& esomeprazole 40mg 8 hourly 30 minutes before meal for 14 days.

Drug: group A : Amoxicillin Esomeprazole HDDT

Group-B

ACTIVE COMPARATOR

Group-B patients will receive levofloxacin containing triple therapy that is 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

Interventions

group A : Amoxicillin Esomeprazole HDDT DRUG

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.

Group-A

group-B : Levofloxacin triple therapy DRUG

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.

Group-B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Dyspeptic patients with positive Rapid urease test \& stool antigen test
• patients giving written informed consent

You may not qualify if:

• Treatment with proton pump inhibitor, H2-receptor antagonist, bismuth preparation within the last 2 weeks or antibiotics within 4 weeks prior to study.
• Previous H. pylori eradication therapy
• Complicated duodenal ulcer patients (active bleeding and perforation)
• Patients with regular intake of NSAIDs or steroids.
• Surgery that might affect gastric acid secretion (upper GI resection or vagotomy)
• Known case of malignancy
• Advanced Co-morbidities (e.g. CLD, CKD, cardio-respiratory failure, known thyroid disease)
• participants who are pregnant, lactating or intend to become pregnant within the duration of the study.

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu sheikh mujib medical university

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Salman Rafat, Mbbs

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salman Rafat, Mbbs

CONTACT

+88019996936611; salmanrafat08@gmail.com

Masudul Alam, Mbbs

CONTACT

+8801718008856; saikot_dmc65@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware about which group of treatment they are getting but the investigator will know about the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: participants will be randomly assigned into two groups- Group A \& Group B. Group A will receive amoxicillin-esomeprazole high dose dual therapy for 14 days. Group B will receive levofloxacin containing triple therapy for 14 days. dyspeptic symptoms,drug side effects \& H.pylori eradication rates will be compared between two groups.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: February 10, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: starting 12 months after publication
• Access Criteria: publishers ,any researcher interested in this field may have access

Locations

BA (1)