Levofloxacin-Doxycycline for Helicobacter Pylori Eradication in Saudi Arabia

NCT02884713 | Completed DMC

• 1 other identifier: RAC # 2131064
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

GASTRITIS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Symptoms response to treatment

  6 weeks

• Factors associated with eradication of H.pylori

  6 weeks

• Adverse events associated with the treatment

  6 weeks

Study Arms (1)

Levofloxacin and Doxycycline and Esomeprazole

EXPERIMENTAL

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; Drug: Doxycycline; Drug: Esomeprazole

Interventions

Levofloxacin 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

Levofloxacin and Doxycycline and Esomeprazole

Doxycycline 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

Levofloxacin and Doxycycline and Esomeprazole

Esomeprazole 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

Levofloxacin and Doxycycline and Esomeprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

MeSH Terms

Conditions

Gastritis

Interventions

Levofloxacin; Doxycycline; Esomeprazole

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Hepatology/Gastroenterology

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 31, 2016
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 31, 2016

Record last verified: 2016-08