Levofloxacin Concomitant Versus Levofloxacin Sequential

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Primary Purpose

Status

Not yet recruiting

Phase

Phase 4

Locations

Syrian Arab Republic

Study Type

Interventional

Intervention

sequential

Levofloxacin 500Mg Oral Tablet

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter Pylori, levofloxacine, concomitant, sequential

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

General Assembly of Damascus Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sequential

concomitant

Arm Description

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

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

Outcomes

Primary Outcome Measures

Eradication rate of Helicobacter pylori infection

Eradication rate of Helicobacter infected patients

Secondary Outcome Measures

Full Information

NCT ID

NCT06065267

First Posted

September 27, 2023

Last Updated

September 27, 2023

Sponsor

Damascus Hospital

1. Study Identification

Unique Protocol Identification Number

NCT06065267

Brief Title

Levofloxacin Concomitant Versus Levofloxacin Sequential

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2, 2024 (Anticipated)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Damascus Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori, levofloxacine, concomitant, sequential

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sequential

Arm Type

Experimental

Arm Description

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

Arm Title

concomitant

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

sequential

Other Intervention Name(s)

Esomeprazole, levofloxacine, metronidazole, amoxicillin

Intervention Description

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

Intervention Name(s)

Levofloxacin 500Mg Oral Tablet

Other Intervention Name(s)

Amoxicilline, Esomeprazol, Tinadizole

Intervention Description

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

Primary Outcome Measure Information:

Title

Eradication rate of Helicobacter pylori infection

Description

Eradication rate of Helicobacter infected patients

Time Frame

8 week from begning of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marouf MH Alhalabi, MD

Phone

+963952781278

Email

e.marouf@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marouf M Alhalabi, MD

Organizational Affiliation

general assambly of damascus hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Assembly of Damascus Hospital

City

Damascus

Country

Syrian Arab Republic

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marouf MI Alhalabi, MD

Phone

+963952781278

Email

e.marouf@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Helicobacter Pylori Infection

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial