Levofloxacin Concomitant Versus Levofloxacin Sequential

NCT ID: NCT06065267

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

sequential

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

Group Type: EXPERIMENTAL

sequential

Intervention Type: 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

concomitant

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

Group Type: ACTIVE_COMPARATOR

Levofloxacin 500Mg Oral Tablet

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Levofloxacin 500Mg Oral Tablet

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

Intervention Type: DRUG

Other Intervention Names

Esomeprazole; levofloxacine; metronidazole; amoxicillin; Amoxicilline; Esomeprazol; Tinadizole

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marouf Alhalabi

head of digestive diseases department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marouf M Alhalabi, MD

Role: PRINCIPAL_INVESTIGATOR

general assambly of damascus hospital

Locations

General Assembly of Damascus Hospital

Damascus, , Syria

Countries

Syria

Central Contacts

Marouf MH Alhalabi, MD

Role: CONTACT

e.marouf@hotmail.com

+963952781278

Facility Contacts

Marouf MI Alhalabi, MD

Role: primary

e.marouf@hotmail.com

+963952781278

References

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.

Reference Type: DERIVED

PMID: 38225650 (View on PubMed)

Other Identifiers

G-9-23

Identifier Type: -

Identifier Source: org_study_id