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
About this trial
This is an interventional treatment trial for GASTRITIS
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.
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
NCT ID
NCT02884713
First Posted
August 11, 2016
Last Updated
August 25, 2016
Sponsor
King Faisal Specialist Hospital & Research Center
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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