5 Day Concomitant Versus 10 Day Sequential Therapy for Eradication of H. Pylori Infection

NCT ID: NCT01544517

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-12-31

Brief Summary

A five day quadruple concomitant therapy is as effective and safe as a 10 day sequential therapy for eradication of H. pylori infection.

Detailed Description

The investigators studied 180 consecutive patients with H. pylori infection who were randomized to 5-day concomitant therapy (90 patients) and to 10-day sequential therapy (90 patients). 6 and 10 weeks after the end of therapy, patients were evaluated for their H. pylori status by 13C Urea Breath Test. Side effects and costs of either regimen were evaluated. In patients whose H pylori status at entry was assessed by endoscopy, culture was performed and antimicrobial resistance was determined

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5d-QCT

5-day eradication regimen consisting in the concomitant administration of esomeprazole 40mg bid + amoxicillin 1g bid + levofloxacin 500mg bid + tinidazole 500mg bid

Group Type: EXPERIMENTAL

Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

Intervention Type: DRUG

amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg

10-day sequential regimen

5 days of esomeprazole 40mg bid + amoxicillin 40mg bid followed by 5 more days of esomeprazole 40mg bid + levofloxacin 500mg bid + tinidazole 500 mg bid

Group Type: ACTIVE_COMPARATOR

Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

Intervention Type: DRUG

amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg

Interventions

Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)

amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg

Intervention Type: DRUG

Other Intervention Names

proton pump inhibitors

Eligibility Criteria

Inclusion Criteria

• H. pylori-infected patients who were at least 18 years of age and who had never received H. pylori eradication treatment were included in the study.

Exclusion Criteria

• previous treatment for H. pylori infection,
• use of inhibitors of acid secretion and/or antibiotics during the 6 weeks before the study,
• gastrointestinal malignancy,
• previous gastro-oesophageal surgery,
• severe concomitant cardiovascular,
• respiratory or endocrine diseases,
• clinically significant renal or hepatic disease,
• hematologic disorders,
• any other clinically significant medical condition that could increase risk,
• history of allergy to any of the drug used in the study,
• pregnancy or lactation,
• alcohol abuse,
• drug addiction,
• severe neurologic or psychiatric disorders, and
• long-term use of corticosteroids or anti-inflammatory drugs.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Marco Romano

Associate Professor of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marco Romano, MD

Role: PRINCIPAL_INVESTIGATOR

Second University of Naples Medical School

Locations

Dipartimento di Internistica Clinica e Sperimentale, SUN

Naples, Napoli, Italy

Countries

Italy

Other Identifiers

EudraCT 2010-02464415

Identifier Type: -

Identifier Source: org_study_id