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Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

NCT ID: NCT02884713

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-04-30

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.

Conditions

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GASTRITIS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levofloxacin and Doxycycline and Esomeprazole

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

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

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

Doxycycline

Intervention Type DRUG

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

Esomeprazole

Intervention Type DRUG

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

Interventions

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Levofloxacin

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

Doxycycline

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

Esomeprazole

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

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Fahad Alsohaibani

Consultant, Hepatology/Gastroenterology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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RAC # 2131064

Identifier Type: -

Identifier Source: org_study_id