Levofloxacin Concomitant Versus Levofloxacin Sequential

Phase 4

Not yet recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Levofloxacin 500Mg Oral Tablet; Drug: sequential

• Registration Number: NCT06065267
• Lead Sponsor: Damascus Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-09-27
• Last Update Submitted: 2023-09-27
• Study First Posted: 2023-10-03
• Last Update Posted: 2023-10-03
• Study Start: 2024-01-02
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
concomitant	Levofloxacin 500Mg Oral Tablet	Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen
sequential	sequential	Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen

Primary Outcome Measures

Name	Time	Method
Eradication rate of Helicobacter pylori infection	8 week from begning of treatment	Eradication rate of Helicobacter infected patients

Trial Locations

Locations (1)

General Assembly of Damascus Hospital; 🇸🇾 Damascus, Syrian Arab Republic