Levofloxacin Concomitant Versus Levofloxacin Sequential

NCT06065267 | Not Yet Recruiting Phase 4

• 1 other identifier: G-9-23
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori; levofloxacine; concomitant; sequential

Outcome Measures

Primary Outcomes (1)

• Eradication rate of Helicobacter pylori infection

  Eradication rate of Helicobacter infected patients

  8 week from begning of treatment

Study Arms (2)

sequential

EXPERIMENTAL

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

Drug: sequential

concomitant

ACTIVE COMPARATOR

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

Drug: Levofloxacin 500Mg Oral Tablet

Interventions

sequential DRUG

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

Also known as: Esomeprazole, levofloxacine, metronidazole, amoxicillin

sequential

Levofloxacin 500Mg Oral Tablet DRUG

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

Also known as: Amoxicilline, Esomeprazol, Tinadizole

concomitant

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus Hospital: lead

Study Sites (1)

General Assembly of Damascus Hospital

Damascus, Syria

Location

Related Publications (1)

• Alhalabi M, Almokdad R. Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial. Trials. 2024 Jan 15;25(1):55. doi: 10.1186/s13063-024-07906-3.

  PMID: 38225650 DERIVED

MeSH Terms

Interventions

Esomeprazole; Ofloxacin; Metronidazole; Amoxicillin; Levofloxacin; Tablets; Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Marouf M Alhalabi, MD

  general assambly of damascus hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marouf MH Alhalabi, MD

CONTACT

+963952781278; e.marouf@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of digestive diseases department

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 3, 2023
• Study Start: January 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 3, 2023

Record last verified: 2023-09

Locations

SY (1)