Levofloxacin Concomitant Versus Levofloxacin Sequential

Sponsor

Damascus Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06065267

Collaborator

(none)

150

Enrollment

Location

Arms

41.9

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: sequential Drug: Levofloxacin 500Mg Oral Tablet	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial

Anticipated Study Start Date :

Jan 2, 2024

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: sequential Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen	Drug: sequential amoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week Other Names: Esomeprazole levofloxacine metronidazole amoxicillin
Active Comparator: concomitant Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen	Drug: Levofloxacin 500Mg Oral Tablet Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid Other Names: Amoxicilline Esomeprazol Tinadizole

Arm

Intervention/Treatment

Experimental: sequential

Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen

Drug: sequential

amoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week

Other Names:

Esomeprazole

levofloxacine

metronidazole

amoxicillin

Active Comparator: concomitant

Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen

Drug: Levofloxacin 500Mg Oral Tablet

Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Other Names:

Amoxicilline

Esomeprazol

Tinadizole

Outcome Measures

Primary Outcome Measures

Eradication rate of Helicobacter pylori infection [8 week from begning of treatment]
Eradication rate of Helicobacter infected patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
Positive rapid urease test (CLOtest).
Histologic evidence of H. pylori by modified Giemsa staining.
Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria:

Children and teenagers aged less than 18 years.
Previous eradication treatment for H. pylori.
Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
History of gastrectomy.
Gastric malignancy, including adenocarcinoma and lymphoma,
Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
Contraindication to treatment drugs.
Pregnant or lactating women.
Severe concurrent disease.
Liver cirrhosis.