LOAD VS Levofloxacine Concomitant

November 8, 2020 updated by: Marouf Alhalabi, Damascus Hospital

Comparing the Efficacy of Two Weeks Therapy of Doxycycline,Levofloxacin,Tinidazole Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population

Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Doxycyclien
Measure eradication rate of Helicobacter pylori infection with Doxycycline,Levofloxacien,tinadizole
Drug: Doxycycline
Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole 500 bid
Other Names:
  • Tinadizole
  • Esomeprazole
  • levofloxacine
Active Comparator: Levofloxacine
Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole,amoxicilline
Drug: Levofloxacin 500mg
Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
Other Names:
  • Tinadizole
  • Amoxicilline
  • Esomeprazol

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus Hospital

Investigators

  • Principal Investigator: Marouf M Alhalabi, MD, general assambly of damascus hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2020

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

May 30, 2024

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 8, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 8, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G-10-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

Within 5 year of study completion

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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