Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

GASTRITIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884713
• Other study ID #: RAC # 2131064
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: August 25, 2016
• Start date: June 2013
• Est. completion date: April 2014

Study information

• Verified date: August 2016
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Research Advisory Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• GASTRITIS

Intervention

Drug:
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Factors associated with eradication of H.pylori	Physiological parameter: such as age and gender and prior use of triple or sequential therapy	6 weeks	No
Secondary	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	Yes