Levofloxacin Concomitant Versus Levofloxacin Sequential

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06065267

Enrollment

150

Registered

2023-10-03

Start date

2024-01-02

Completion date

2027-06-30

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori, levofloxacine, concomitant, sequential

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

Interventions

DRUGsequential

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

DRUGLevofloxacin 500Mg Oral Tablet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Countries

Syria

Contacts

Primary ContactMarouf MH Alhalabi, MD

e.marouf@hotmail.com+963952781278

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026