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Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

Primary Purpose

GASTRITIS

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levofloxacin
Doxycycline
Esomeprazole
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GASTRITIS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age or older
  • Received previous treatment with triple therapy, sequential therapy or both
  • Has evidence of persistence H. pylori infection by a positive urea breath test (UBT), histology or rapid urease test (HP Fast. GI supply™, PA, USA)

Exclusion Criteria:

  • Previously treated with quadruple or levofloxacin-based therapy
  • Had an allergy to doxycycline, levofloxacin or esomeprazole
  • Pregnant or lactating
  • Significant hepatic, renal, or cardiopulmonary disorders, or active malignancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Levofloxacin and Doxycycline and Esomeprazole

    Arm Description

    The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily

    Outcomes

    Primary Outcome Measures

    Eradication rate of second line levofloxacin- doxycycline based therapy for H. pylori eradication after failed fisrt line therapy using Urea Breath Test and its association with symptoms resolution.
    The primary endpoint was a negative UBT after a minimum of 6 weeks after completion of treatment

    Secondary Outcome Measures

    Symptoms response to treatment
    Will use a visual analogue scale (VAS) on a questionnaire to look at the symptoms pre and post treatment and see if the eradication of h.pylori helped to resolve the symptoms
    Factors associated with eradication of H.pylori
    Physiological parameter: such as age and gender and prior use of triple or sequential therapy
    Adverse events associated with the treatment
    Will use a visual analogue scale (VAS) on a questionnaire (such as abdominal pain, headache, dizziness, and rash)

    Full Information

    First Posted
    August 11, 2016
    Last Updated
    August 25, 2016
    Sponsor
    King Faisal Specialist Hospital & Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02884713
    Brief Title
    Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia
    Official Title
    Efficacy of Levofloxacin-Doxycycline Based Rescue Therapy for Helicobacter Pylori Eradication: A Prospective Open-label Trial in Saudi Arabia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    April 2014 (Actual)
    Study Completion Date
    April 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    King Faisal Specialist Hospital & Research Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Helicobacter pylori (H. pylori) eradication is achieved in 60-80% with first-line therapy. Different second-line therapeutic options are available. However, the success of second-line therapy has not been addressed or reported from Saudi Arabia. Objectives The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment.
    Detailed Description
    A prospective, open-label, single arm study was conducted. Patients were recruited from a tertiary care hospital in Saudi Arabia from June 2013 to April 2014. A total of 55 patients had previously received standard triple therapy and/or sequential therapy in the period from 2011 to 2014 and failed to eradicate the infection. The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily. Urea-breath-test (UBT) was done at a minimum of 6 weeks after completion of the treatment to confirm the H. pylori eradication. Compliance and tolerability of the regimen were also assessed.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Levofloxacin and Doxycycline and Esomeprazole
    Arm Type
    Experimental
    Arm Description
    The rescue treatment was given for ten days consisting of levofloxacin 500 mg once daily, doxycycline 100 mg twice daily, and esomeprazole 20 mg twice daily
    Intervention Type
    Drug
    Intervention Name(s)
    Levofloxacin
    Intervention Description
    The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Doxycycline
    Intervention Description
    The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Intervention Description
    The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment
    Primary Outcome Measure Information:
    Title
    Eradication rate of second line levofloxacin- doxycycline based therapy for H. pylori eradication after failed fisrt line therapy using Urea Breath Test and its association with symptoms resolution.
    Description
    The primary endpoint was a negative UBT after a minimum of 6 weeks after completion of treatment
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Symptoms response to treatment
    Description
    Will use a visual analogue scale (VAS) on a questionnaire to look at the symptoms pre and post treatment and see if the eradication of h.pylori helped to resolve the symptoms
    Time Frame
    6 weeks
    Title
    Factors associated with eradication of H.pylori
    Description
    Physiological parameter: such as age and gender and prior use of triple or sequential therapy
    Time Frame
    6 weeks
    Title
    Adverse events associated with the treatment
    Description
    Will use a visual analogue scale (VAS) on a questionnaire (such as abdominal pain, headache, dizziness, and rash)
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older Received previous treatment with triple therapy, sequential therapy or both Has evidence of persistence H. pylori infection by a positive urea breath test (UBT), histology or rapid urease test (HP Fast. GI supply™, PA, USA) Exclusion Criteria: Previously treated with quadruple or levofloxacin-based therapy Had an allergy to doxycycline, levofloxacin or esomeprazole Pregnant or lactating Significant hepatic, renal, or cardiopulmonary disorders, or active malignancy.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Not decided yet.

    Learn more about this trial

    Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

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