Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

King Faisal Specialist Hospital & Research Center

Status: Completed

Conditions: GASTRITIS

Treatments: Drug: Esomeprazole; Drug: Levofloxacin; Drug: Doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT02884713

RAC # 2131064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Levofloxacin and Doxycycline and Esomeprazole

Experimental group

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

Treatment:

Drug: Esomeprazole

Drug: Doxycycline

Drug: Levofloxacin