Levofloxacin Concomitant Versus Levofloxacin Sequential

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06065267
• Other study ID #: G-9-23
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: September 2023
• Source: Damascus Hospital
• Contact: Marouf MH Alhalabi, MD
• Phone: +963952781278
• Email: e.marouf[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

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
• Levofloxacin 500Mg Oral Tablet
Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Locations

Country	Name	City	State
Syrian Arab Republic	General Assembly of Damascus Hospital	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus Hospital

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate of Helicobacter pylori infection	Eradication rate of Helicobacter infected patients	8 week from begning of treatment