Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Levofloxacin-Doxycycline Based Rescue Therapy for Helicobacter Pylori Eradication: A Prospective Open-label Trial in Saudi Arabia

Conditions
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GASTRITIS

Intervention / Treatment
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* Drug: Levofloxacin
* Drug: Doxycycline
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levofloxacin and Doxycycline and Esomeprazole<br>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 | Drug: Levofloxacin<br>* 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<br>Drug: Doxycycline<br>* 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<br>Drug: Esomeprazole<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks | 
| Factors associated with eradication of H.pylori | Physiological parameter: such as age and gender and prior use of triple or sequential therapy | 6 weeks | 
| Adverse events associated with the treatment | Will use a visual analogue scale (VAS) on a questionnaire (such as abdominal pain, headache, dizziness, and rash) | 6 weeks |